CoNTeNTS

FOREWORD A MESSAGE FROM OUR CO-DIRECTORS HIV-NAT CLINICAL TRIALS NETWORK INTERNATIONAL ADVISORY BOARD 2012 COLLABORATORS OVERVIEW OF HIV-NAT STUDIES PHARMACOKINETIC STUDIES CLINICAL RESEARCH PROGRAMS IN CO-VIRAL & VIRAL INFECTIONS CLINICAL RESEARCH PROGRAMS IN CO-TUBERCULOSIS INFECTIONS LONG TERM COHORT ANALYSIS STRATEGY STUDIES NEW DRUG DEVELOPMENT SEXUAL HEALTH OTHERS PEDIATRIC AND YOUTH RESEARCH PROGRAMS HIV-NAT TEAMS PUBLICATIONS & WRITINGS PRESENTATIONS AT CONFERENCES AND MEETINGS HIV-NAT RESEARCH LABORATORY THE VACCINE & CELLULAR IMMUNOLOLGY LABORATORY EDUCATION & DEVELOPMENT PROGRAM 15TH THE BANGKOK INTERNATIONAL SYMPOSIUM ON HIV MEDICINE PARTNERSHIPS COMMUNITY OUTREACH PROGRAMS ACKNOWLEDGEMENTS SPONSORS 03 04 05 06 07 10 14 15 19 20 23 26 28 29 31 36 40 45 50 54 56 60 62 77 83 84

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Foreword
It gives me great pride to present the 16th annual report from the HIV Netherlands Australia Thailand Research Collaboration. Its pages highlight the dedication and professionalism HIV-NAT possesses in fighting HIV/AIDS through different avenues of research, knowledge dissemination, activities and campaigns.

Phan Wannamethee Secretary General Thai Red Cross Society

HIV-NAT started the year with the 15th Bangkok International Symposium on HIV Medicine in January, which was attended by more than 700 physicians from all over the world. Additionally, various trainings on HIV/AIDS were organized throughout the year to disseminate knowledge and information on clinical research and HIV infection management to health care professionals from Thailand and 9 countries in the region. Throughout 2012 HIV-NAT has stayed committed to improving HIV care in Thailand and Southeast Asia through cutting edge research and quality training for health care providers. Results from research conducted at HIV-NAT have been recognized in national and international treatment guidelines. HIV-NAT also engaged in public awareness activities. These included events that promote non-stigmatization and non-discrimination of people living with HIV that strive to improve quality of life for people living with HIV. HIV-NAT and the Thai Red Cross AIDS Research Centre joined hands with the Ministry of Public Health, UNAIDS, the Bangkok Metropolitan Administration and various NGOs in advancing Thailand towards the Getting to Zero goal. A series of seminars that targeted Getting to Zero messages, where zero refers to zero deaths, zero new infections and zero discrimination, were organized. This created a forum for private businesses, the media, entertainment companies, people living with HIV, HIV/AIDS experts and policy makers to voice shared opinions. Common ground was created and brainstorming was used to harness ideas that will drive Thailands move toward zero. The Wish Your Love fundraising campaign for HIV-positive children and families was also launched in 2012. This was made possible by many actors and celebrities, and a generous public who endorsed the campaign. HIV-NAT has grown and achieved much in 2012. However, the organization and its special focus as a research facility for HIV/AIDS will continue to stay true to its vision of becoming a leading center of training for HIV/AIDS and a champion for Getting to Zero. Essentially, the success of 2012 acts as a catalyst for HIV-NAT. I believe that 2013 will see HIV-NAT gaining greater ground in Southeast Asia and the world for life saving research that will enable increased access to treatment for people living with HIV.

Phan Wannamethee

Secretary General, Thai Red Cross Society Chairman, HIV-NAT international Advisory Board

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A MeSSAGe FroM oUr Co-dIreCTorS

(left to right) Joep M.A. Lange Praphan Phanuphak David A. Cooper

2012 has been an extraordinary year of growth for research at HIV-NAT. Seventy-two clinical studies were conducted this year alone. HIV-NAT continues to be the country coordinator for US National Institutes of Health-funded trials on when to start antiretrovirals in adults (START) and in children (PREDICT). Through the Kirby Institute of Infection and Immunity, HIV-NAT is coordinating multi-site randomized clinical trials on appropriate dosing of ART (LASA, ENCORE) and regimen for second line. By partnering with amfAR/Treat Asia, the first hepatitis C treatment study will be available to patients in Thailand in 2013. Through close collaboration with the TREAT Asia Network, HIV-NAT is the regional coordinating center for several pediatric studies in 4 countries in South East Asia. In 2012, HIV-NAT published 43 articles in peer-reviewed journals including the Lancet Infectious Disease publication of the PREDICT study results. HIV-NAT is committed to improving knowledge to better the care delivered to adults and children with HIV in Thailand and the region.
We now have 110 staff who work tirelessly to advance HIV research and provide care to almost 2000 adults and children with HIV at our center. We recognize the medical, financial and social challenges children and families with HIV face, and HIV-NAT launched the Wish Your Love fundraising campaign in August 2012 to help these vulnerable children and youth reach their greatest potential. We are delighted to welcome Professor Frits van Griensven to our organization as the Senior Advisor on HIV Prevention. Dr. Frits is a world renowned expert in HIV epidemiology and HIV prevention. He will play an important role in HIV-NAT and The Thai Red Cross AIDS Research Centre (TRCARC)s goal to reduce new HIV infections in Thailand and in the region. In collaboration with the Ministry of Public Health, HIV-NAT/ TRCARC has begun the first Test and Treat study in Thai men who have sex with men (MSM). HIV-NAT/ TRCARC is coordinating a study to promote HIV testing and linkage to care in MSM from Bangkok, Jakarta and Indonesia. We are committed to working towards achieving UNAIDSs goal of zero new HIV infection. Finally, we hope that you will find this annual report informative and we welcome national and international collaboration. On behalf of the HIV-NAT team, we would like to extend our gratitude to collaborators and sponsors for their unwavering support and to our patients for their continued support, commitment and participation in studies.

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HIV-NAT CLINICAL TRIALS NETWORK

CHIANG MAI
NAKORNPING HOSPITAL SANPATONG HOSPITAL

CHIANG RAI
CHIANG RAI PRACHANUKROH HOSPITAL

KHON KAEN
SRINAGARIND HOSPITAL, KHON KAEN UNIVERSITY KHON KAEN HOSPITAL

BANGKOK
HIV-NAT TRCARC CHULALONGKORN HOSPITAL SIRIRAJ HOSPITAL, MAHIDOL UNIVERSITY BAMRASNARADURA INSTITUTE RAMATHIBODHI HOSPITAL BANGKOK METROPOLITAN ADMINISTRATION MEDICAL COLLEGE & VAJIRA HOSPITAL TAKSIN HOSPITAL

CHON BURI
CHONBURI REGIONAL HOSPITAL QUEEN SAVANG VADHANA MEMORIAL HOSPITAL

CHANTABURI
PRAPOKKLAO HOSPITAL

PHNOM PENH
NATIONAL PEDIATRIC HOSPITAL SOCIAL HEALTH CLINIC

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INTerNATIoNAL AdVISorY BoArd 2012

1 Mr. Phan Wannamethee (Chairman)
Secretary General The Thai Red Cross Society, Bangkok, Thailand

Dr. Tej Bunnag

Assistant Secretary General The Thai Red Cross Society, Bangkok, Thailand

Prof. Emeritus Praphan Phanuphak

Director of The Thai Red Cross AIDS Research Centre, Thai Red Cross Society, Bangkok, Thailand

Prof. David A Cooper

Director of The Kirby Institute for infection and immunity in society (formerly known as the National Centre in HIV Epidemiology and Clinical Research); The University of New South Wale Sydney, Australia

Prof. Sean Emery

National Centre in HIV Epidemiology and Clinical Research The University of New South Wale Sydney, Australia

Prof. Joep M A Lange

Professor of Medicine, Center for Poverty-related Communicable Diseases Academic Medical Center, University of Amsterdam Executive Scientific Director, Amsterdam Institute for Global Health& Development Co-director HIV-NAT

Prof. Martin Grobusch

Professor of Medicine Dep. of Infectious Diseases, Tropical Medicine and HIV/AIDS AMC (Academic Medisch Centrum) of the University of Amsterdam, Amsterdam

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Assoc. Prof. Sophon Napathorn Prof. Ploenchan Chetchotsakd Dr. Timothy Holtz

Dean, Faculty of Medicine, Chulalongkorn University Bangkok, Thailand

Faculty of Medicine, Khonkaen University, Khonkaen, Thailand

Director, HIV/STD Research Program Thailand MOPH-US CDC Collaboration, Ministry of Public Health, Nonthaburi, Thailand

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Dr. Annette Sohn Dr. Viseth Ngauy

amfAR Vice President of Global Initiatives and Director, TREAT Asia Bangkok, Thailand

Chief, Chief of the Department of Retrovirology, AFRIMS USAMC-AFRIMS Bangkok, Thailand

Professor of Medicine, Faculty of Medicine, Chiang Mai University Former Director, The Research Institute for Health Sciences (RIHES)

Prof. Thira Sirisanthana

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CoLLABorATorS
INTERNATIONAL COLLABORATORS
AUSTRALIA THE NETHERLANDS
The Kirby Institute for Infection and Immunity in Society, formerly known as the National Centre in HIV Epidemiology and Clinical Research, University of New South Wales, Sydney
David A. Cooper (HIV-NAT co-director), Sean Emery, Sarah Pett, Cate Carey, Mark Boyd, Rebekah Puls, Carlo Dazo, David Courtney-Rodgers, Natalie Espinosa, Jessica Taylor, Alli Humphries, Courtney Bendall, Gail Matthews, Greg Dore, Pip Marks, Amanda Erratt, Megan Evans, Leanne Kearney, Nisha Seneviratne, Mee Ling Munier, Anthony Kelleher, Hila Haskelberg, Maria Arriaga, Christoph Boesecke, Matthew Law, Di Carey, Anna Donaldson, Kymme Courtney-Vega, and Maja Berilazic

Amsterdam Institute for Global Health and Development (AIGHD) and University of Amsterdam

Joep M.A. Lange (HIV-NAT co-director), Ferdinand Wit, Peter Reiss, Remko van Leeuwen, Janneke van de Wijgert, Jacqueline van Tongeren, Martin Grobusch, Frank van Leth, and Mark van der Valk

Radboud University, Nijmegen Medical Center (Clinical Pharmacology)

David Burger

SINGAPORE

National Healthcare Group Pte Ltd

Lawrence Lee Soon-U

Monash University, Melbourne Infectious Diseases Unit, The Alfred Hospital, Melbourne
Sharon Lewin, Jennifer Audsley and Megan Crane

SWITZERLAND

Victorian Infectious Diseases Service, Royal Melbourne Hospital, Melbourne

Joe Sasadeusz and Stephen Locarnini

Geneva University Medical School, Geneva University Hospital

Bernard Hirschel and Alexandra Calmy

Victorian Infectious Diseases Reference Laboratory, Victorian Infectious Diseases Service, Royal Melbourne Hospital, Melbourne
Scott Bowden

THE UNITED STATES OF AMERICA (USA)

Lab of Neuro Imaging University of California Los Angeles, School of Medicine, Los Angeles
Paul Thompson

Royal Perth Hospital

Martyn French

Johns Hopkins Center for Global Health, Division of Infectious Disease, Baltimore
Chloe Thio

CAMBODIA

Family Health International

Laurent Ferradini

Memory and Aging Center at University of California, San Francisco

Victor Valcour

National Center for HIV/AIDS, Dermatology and STDs (NCHADS)

Mean Chhi Vun and Sarah Huffman

University of Missouri Behavioral Neuroscience/ Neuropsychology, St. Louis, Missouri

Robert Paul

National Pediatric Hospital, Phnom Penh

Vonthanak Saphonn

University of Hawaii, Manoa, Hawaii

Cecilia Shikuma

JAPAN

Wayne State University, Detroit

Chokechai Rongkavilit

Research Institute of Tuberculosis, Japan AntiTuberculosis Association, Tokyo, Japan

Hideki Yanai and Norio Yamada

Vanderbilt Institute for Global Health, Nashville, Tennessee

Vikrant Sahasrabuddhe

INDONESIA
Tuti Parwati

Sanglah Hospital and Faculty of Medicine, Udayana University, Denpasar, Bali, Indonesia Cipto Mangunkusumo Hospital, Jakarta, Indonesia
Evy Yunihastuti

Anal Neoplasia Clinic, University of California, San Francisco

Joel Palefsky

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DOMESTIC COLLABORATORS
BANGKOK
AIDS, TB and STIs Control Division Bangkok Metropolitan Administration, Bangkok, Thailand
Piyathida Smutraprapoot

We Understand Group

Chutima Saisaengjan and Nicha Leehacharoenkul

Children and Youth program SEARCH

Sudrak Lakhonpon, Chutima Ketbumrung and Sangla Najai

Faculty of Medicine, Vajira Hospital, University of Bangkok Metropolitan Administration, Thailand

Warangkana Munsakul

CHANTABURI

Chulalongkorn Hospital

Prapokklao Hospital

Chitsanu Panchareon, Gompol Suwanpimolkul, Opass Pucharoen, Pisith Tangkitvanich, Piyawat Komolmit, Rungsun Rerknimitr, Sukalaya Lerdlum, Surasith Chaithongwongwatthana, Vorasuk Shotelersuk, Wattanee Taweesith, Yingyos Avihingsanon, Leilani Paitoonpong, Voraphoj Nilaratanakul, Nontalee Thongsong, ornvimol Leethong, Paisan Techawaleekul, Suwimon Khusuwan, Kamol Kawkitinarong, Kamolwan Jutivorakool, Kearkiat Praditpornnsilpa, Tawathai Chawatanarat, Surang Triratanachart, Somboon Keelawat, Somchai Niruthisard, Lalana Sansopa, and Patoo Tanpairoj

Chaiwat Ngampiyasakul

CHIANG MAI

Research Institute for Health Sciences (RIHES), Chiang Mai University

Virat Sirisanthana and Khuanchai Supparatpinyo

Nakornping Hospital
Suparat Kanjanavanit

Program for HIV Prevention and Treatment

Jeffrey Parsons, Marc Lallemant, Sylvie Naar-King, Gonzague Jourdain and Nicole Ngo-Giang-Huong

Faculty of Psychology, Chulalongkorn University

Arunya Tuicomepee

Sanpatong Hospital
Virat Klinbuayaem

Phramongkutklao Hospital of the Royal Thai Army

Pichai Saengcharnchai and Pongrak Boonyanurak

CHIANG RAI

Queen Sirikit National Institute of Child Health Rajvithee Hospital

Tawee Chotpitayasunondh and PiyaratSuntarattiwong

Chiangrai Prachanukroh Hospital, Chiangrai, Thailand

Pacharee Kantipong, Pisanu Kantipong and Rawiwan Hansudewechakul

Pairaj Kateruttanakul, Tavatchai Jariyasethpong and Pairaj Kateruttanakul

Mea Chan Hospital, Chiang Rai Phan Hospital, Chiang Rai

Sudanee Buranabenjasthen and Suvimon Yama

Ramathibodi Hospital

Sasisopin Kiertiburanakul, Somnuek Sungkanuparph, Suwat Benjaponpitak and ChonametTechasaensiri

Noprada Panyayeun and Ploy Chaisawad

Siriraj Hospital

Mae Suai Hospital, Chiang Rai Mae Sai Hospital, Chiang Rai

Kulkanya Chokephaibulkit, Surapol Suwanagool, Wichai Techasathit, Winai Ratanasuwan, Thanomsak Anekthananon

Atsanai Kittipanyaworakun and Picheth Kanphakrue

Jariyarat Nitipatkosum and Suratsawadee Sitiyos

Taksin Hospital

Supunnee Jirajariyavej

Phaya Meng Rai Hospital, Chiang Rai

Ampawan Srikruttranun and Preyarat Netsuwan

The Thai Red Cross AIDS Research Centre

Mana Khongpatanayothin, Nittaya Phanuphak, Nipat Teeratakulpisarn, Somsong Teeratakulpisarn, Jureeporn Jantarapakde, and PailinSuvanmala

Somdej Phra Yanna Sangworn Hospital, Chiang Rai

Tawatchai Jaikamwang and Malai Jaisuda

UNICEF Thailand

Robert Gass and Nonglak Boonyabuddhi

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Thoeng Hospital, Chiang Rai

Suthida Liengchawengwong and Jirattikarn Sukying

PETCHABURI

Petchaburi Hospital
Witaya Petdachai

AIDS ACCESS Foundation, Chiang Rai Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association
Maitri Oongern, Saiyud Moolphate, and Thittaya Kulprayong

Namphung Plangruan and Songsopa Wongsa

PHITSANULOK

Buddhachinaraj Hospital
Narong Lertpienthum

SURIN

Surin Hospital

CHONBURI

Pakarat Sangkla

Chonburi Hospital

Chureeratana Bowonwattanuwong

SURATTHANEE
Songsak Serirodom

Queen Savang Vadhana Memorial Hospital

Wicharn Luesomboon, Tanate Jadwattanakul

Suratthanee Hospital

KHON KAEN

UBON RATCHATHANI
Pramot Srisamang

Srinagarind Hospital, Khon Kaen University, Khon Kaen, Thailand

Sappasitthiprasong Hospital

Ploenchan Chetchotisakd, Pagakrong Lumbiganon, Siriluck Anunnatsiri, Pope Kosalaraksa and Piroon Mootsikapun

UDONTHANI

Udonthani Hospital
Wanida Chatchomchuan

Khon Kaen Hospital, Khon Kaen, Thailand

Niramon Leeratanapetch, Pornrith Sutthiman and Wattanachai Susaengrat

NONTHABURI

Bamrasnaradura Infectious Disease Institute, Nonthaburi, Thailand

Jurai Wongsawat, Weerawat Manosuthi and Wisit Prasithsirikul

Central Chest Hospital

Charoen Chuchottaworn

Department of Disease Control, Ministry of Public Health, Nonthaburi, Thailand

Somsak Akkasilp, Petsi Sirinirund, and Cheewanan Lertpiriyasuwat

Division of HIV/AIDS Prevention, Thailand Ministry of Public Health US Centers for Disease Control and Prevention Collaboration, Ministry of Public Health, Nonthaburi, Thailand
Frits van Griensven, Timothy H. Holtz, Supaporn Chaikummao

National Health Security Office (NHSO)

Sorakij Bhakeecheep and Winai Sawasdivorn

Please note that thislist is not exclusive nor exhaustive. Since new research studies are developed and existing studies change, it is possible that some collaborators may not be listed.

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OVERVIEW OF HIV-NAT STUDIES

In 2012, HIV-NAT conducted a total of 72 studies, 44 of which were conducted on adults and 28 on children/adolescents. There are 6 pharmacokinetic studies of which 3 are done in children and 2 in adolescents. There are 13 co-viral and viral studies: 4 hepatitis, 4 human papilloma virus (HPV), 4 inuenza, and 1 cytomegalovirus (CMV) studies of which 2 has been completed (HPV and CMV studies). There are three Tuberculosis (TB) studies, 9 cohort studies and 5 strategic studies with 14 additional substudies. For the rst time this year, we have added a new section of studies to accommodate the increase in sexual health studies. There are four sexual health studies and one substudy. Two more sexual health studies were awaiting IRB approval at time when this report was sent to press (December 2012). There are 22 pediatric studies and more on the way. Overall, there are 11 ongoing and 11 completed studies. At the time of writing this, there were 6 studies pending IRB approval (3 pediatric studies, 1 hepatitis study, 1 pharmacokinetic study and 1 TB study). Five studies are awaiting funding approval (3 pediatric studies, 1 HCV study and 1 elite controllers).

is year, HIV-NAT has undergone some major internal changes but exciting changes. e Clinical Research Associates (CRAs) now handles all IRB preparations, submissions and follow-ups. e medical team has two sta to help with it so more work can be completed in a timely manner: medical coordinator and grant manager. Some of the nurses have undergone training to become nurse practioners to help see adult cohort patients.

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Our biostatisticians, CRAs, lab and nurses participate in presenting the latest articles in English at journal club with the MDs. Our nurses also present interesting or problematic cases in our Clinical Case Discussion sessions held monthly. ey are undergoing additional training so they can write up study protocols to conduct their own studies as well as manuscripts. A new category of studies has been added this year due to an increased number of sexual health studies by our obstetrician. Many of our clinical trial research nurses have shown enthusiastic interest in this eld. As Ms. Chuleeporn Wongvoranet stated, e sexual and reproductive health (SRH) research for women living with HIV/ AIDS is fundamental to their well-being and that of their partners and children. Improving womens sexual and reproductive health, HIV treatment and HIV prevention among couples are important factors. HIV-NAT has conducted several sexual and reproductive health (SRH) research studies so we can better understand sexual life and reproductive health to provide a new standard of reproductive health service to HIV-infected women and their partners. Ms. Parawee ongpaeng added, Sexual health is a state of physical, mental and social well-being in relation to sexuality. According to WHOs denition, it requires a positive and respectful approach to sexuality and sexual relationships, as well as the possibility of having pleasurable and safe sexual experiences, free of coercion, discrimination and violence. We cannot ignore sexual health because the burden of morbidity has increased due to misperception. is is unacceptably high, especially in a eld that is preventable if we have the correct medical knowledge. Sexual health is part of the human development just as men or women are essential for economic and social stability and progress in all societies. Providing health care by the medical team should not only focus on the inequality of knowledge but also from cultural and economic dierences. ats why I am interested in sexual health.

In addition, this year we are seeing an increase number of studies being conducted in the adolescent population as many of our pediatric patients are starting to become teenagers and encountering a dierent set of problems. Even within the adolescent population, there are distinct dierences between the perinatally HIV-infected adolescents versus the behaviorally HIV-infected youths. ere are so many unanswered questions, especially in the eld of HIV which is always changing at a rapid pace. HIV-NAT has dedicated itself to continue to conduct quality research by addressing those issues relevant and important to the country, region and worldwide. It is dicult to keep abreast of all the new developments but our dedicated sta and collaboration with various organizations and institutions have made this possible. HIV-NAT would like to acknowledge all of its contributors for their unwavering support.

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NUMBER OF STUDIES IN 2011 vs 2012

35 30 25 20 15 35 10 30 5 25 0 20 15 10 2011 2012

PK viral coinf TB Cohort Stragety New Drug Sex Oth PK Ped coinf viral TB Cohort Stragety New Drug Sex Oth

Please note that this year, each substudy 5 is not counted as a study. Instead, the main study is counted. For example, the 0 START study (Strategic study) has 10 2011 substudies but is counted as only 1 study. In addition, this year we have fewer large studies but more substudies. 14
12 10 8 14 6 12 4 10 2 8 0 PK 6 Viral coinf TB Cohort

PK Viral coinf. TB Cohort Strategy New Drug EAP Sex Oth Ped.

KEY TO ABBREVIATIONS Ped Pharmacokinetics Studies Clinical Research Programs in Co-Viral and Viral Infections Clinical Research Programs in HIV/TB Co-Infections Long Term Cohort Analysis 2012 Strategy Studies New Drug Development Expanded Access Programs completed Sexual Health Studies Others ongoing Pediatric and Youth Research Programs
just started

completed ongoing just started

Strategy New Drug

Oth

Sex

Ped

4 2

0 PK Viral coinf TB Cohort Strategy New Drug Oth Sex Ped

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OVERALL THAI SUPPORT

Government agencies Commission of Higher Education, Ministry of Education (CHE) Ministry of Public Health (MOPH) National Health Security Oce (NHSO) National Research Council of ailand Social Security Oce (SSO) ai Research Fund National Research University (NRU) Department of Disease Control (DDC) Pharmaceutical partner Government Pharmaceutical Organization Academic organization Chulalongkorn University Funding agency e Aligning Care and Prevention of HIV/AIDS with Government Decentralization to Achieve Coverage and Impact: ACHIEVED Project (Global fund ailand) Research organizations HIV-NAT ai Red Cross AIDS Research Centre number of studies 2 2 4 4 1 1 3 2 2 12

2 5 4

OVERALL INTERNATIONAL SUPPORT

Governmental agency National Institute of Health (NIH) Pharmaceutical partners Abbott Bristol-Myers Squibb Gilead Sciences Matrix Merck & Co., Inc ROCHE Pharmaceutical Tibotec Pharmaceuticals ViiV Glaxo Smith Kline Academic organizations Foundation for AIDS Research, United States (amfAR)/TREAT Asia e Kirby Institute for Infection and Immunity in Society, Sydney, Australia Research organization Pediatric European Network for Treatment of AIDS (PENTA) Funding agency UNICEF Charity Art AIDS Fund number of studies 8 1 4 3 1 1 1 6 1 1 12 6 3 1 1

Please note that thislist is not exclusive nor exhaustive. Since new research studies are developed and existing studies change, it is possible that some collaborators may not be listed.

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PHARMACOKINETIC STUDIES
There are 6 pharmacokinetic studies, 3 of which are done in children and 2 in adolescents. All of the pediatric pharmacokinetic (PK) studies are ongoing. One adult pharmacokinetic study was completed in 2012. The manuscript for this study was drafted at the time this annual report was published (December 2012).

HIV-NAT is a pioneer in studying PK of antiretrovirals in ai patients. HIV-NATs studies have shed light on the uniqueness in PK and pharmacogenomic prole of Asians. HIV-NAT studies have consistently shown that ais have high NNRTI and PI drug concentrations compared to those reported in Caucasians. is has led to changes in the ai national guideline to use lower than manufacturerrecommended dosages for several antiretroviral drugs. Using low dose antiretrovirals could lead to reduce side eects and cost; an important consideration for resource-limited settings such as ailand. Sasiwimol Ubolyam erapeutic Drug Monitoring (TDM) Studies HIV-NAT 118 erapeutic Drug Monitoring of the generic tenofovir/lamivudine/efavirenz tablets in the ai HIV-infected Patient is is a prospective, open-label, single arm study that assesses the ecacy and safety of xed dose combination of TDF/3TC/EFV. Target/Enrolled: 100/100 Status: Opened on February 2, 2010. Completed Funding: Matrix Laboratory Results: e generic FDC of TDF/3TC/EFV was well tolerated and ecacious. Our ndings lend support to the use of this generic FDC as rst-line antiretroviral therapy in resource limited settings. Presentation: Maekanantawat W, Avihingsanon A, ainsanguankul W, Wongsabut J, Gorowara M, Ramautarsing R, Clarke A, Hsu D, Ruxrungtham K. Safety and ecacy of once daily single generic xed drug combination tablet of tenofovir, lamivudine and efavirenz among HIV infected ais. [Poster # P312]was presented at the International Congress on Drug erapy in HIV. Glasgow, Glasgow, UK. 11-15 November 2012 HIV-NAT 131 Pharmacokinetics Study of Tenofovir in HIV-infected ai Children using Tenofovir-based Regimen is study will assess the pharmacokinetics of Tenofovir in HIV-infected ai children using Tenofovir-based regimen. Target/Enrolled: 32/32

Status: Closed May 8, 2012 Site: Khon Kaen University Funding: Ratchadaphiseksomphot Fund, Faculty of Medicine, Chulalongkorn University Results: ai children achieved similar TDF exposures to Western children and adults. Renal toxicity was uncommon but continued monitoring is required to ascertain long-term eects. TDF PK in adolscents HIV-NAT 145 e objective of this study is to describe the PK parameters of TDF when administered with PIs in HIV-infected Asian adolescent aged 12-<18 years Status: Opened on Oct. 6, 2011. Ongoing Target/Enrolled: 20/20 Sites: HIVNAT Funding: e American Foundation for AIDS Research (amfAR), erapeutics Research, Education, and AIDS Training in Asia (Treat Asia) TDF PK in adolscents HIV-NAT 145.1 e objective of this study is to describe mid-dose concentration of TDF in children aged 8 - <18 years using TDF in various dosages Status: Opened on June 2012. Ongoing Target/Enrolled: 50/20 Sites: 2 sites ailand and Vietnam Funding: amfAR, Treat Asia HIV-NAT 146 e study of atazavanir/ritonavir-based HAART in ai HIV-infected children is trial will study the pharmacokinetics of atazanavir/ritonavir (ATV/r) in HIV-1 infected ai children. Status: Opened on July 14, 2011. Ongoing Target/Enrolled: 20/20 Collaborators: amfAR, Treat Asia, NHSO for antiretrovirals and certain laboratory testing, and GPO for ritonavir tablet 100 mg, Department of Pediatrics, Ramathibodi Hospital, Mahidol University Funding: amfAR, Treat Asia, NHSO, and GPO

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Presentation: Bunupuradah T, Techasaensiri C, Keadpudsa S, ammajaruk N, Srimuan A, Sahakijpicharn T, Prasitsuebsai W, Ananworanich J, Puthanakit T. on behalf of the HIV-NAT 146 study team. Pharmacokinetics of atazanavir/ritonavir among ai HIV-infected children concomitantly taking tenofovir disoproxil fumarate. Oral presentation A-477-0009-00205 will be presented at the 6th AsianCongressof Pediatric Infectious Diseases (ACPID 2012). BMICH, Colombo, Sri Lanka. 28 Nov 1 Dec 2012 HIV-NAT 167 Pharmacokinetics of Abacavir once daily vs. twice daily in HIV-infected ai Children is study will evaluate pharmacokinetic of abacavir in ai HIV-infected children. Status: Open Feb 23, 2012 Target/Enrolled: 30/30 Collaborator: PHPT Funding: amfAR, Treat Asia

CLINICAL RESEARCH PROGRAMS IN CO-VIRAL AND VIRAL INFECTIONS

There are 13 co-viral and viral studies. There are 4 hepatitis, 4 human papilloma virus (HPV), 4 inuenza, and 1 cytomegalovirus (CMV) studies of which 2 has been completed (HPV and CMV studies). From the 4 hepatitis studies, 2 are cohort studies for HBV and 1 is an HCV study. Our hepatitis cohort is one of the largest in the world. Other coinfections studies are currently in the pipeline awaiting for funding and/or IRB approval.
Hepatitis co-infection, both HBV and HCV, continues to be one of the leading causes of death among HIV infected patients worldwide despite having available and adequate treatment for HBV whereas for HCV, treatment continues to remain elusive. Furthermore, hepatitis co-infection with HIV accelerates the disease progression. Because of this, HIV patients are also screened for hepatitis and vice versa. Monitoring disease progression by noninvasive technique such as broscan has shown high promise and is currently being used in several of our hepatitis/brosis studies and substudies. On the other hand, with an increase in cervical and anal cancer among HIV-infected patients, more attention is now also given to HPV. As a result of this, both HIV-infected men and women are recommended to have anal pap smear and pap smears once per year regardless whether the previous result was normal. In ailand, the TRC-ARC is the only place that oers this new screening tool anal pap smear. HIV-NAT 098 is is a prospective, observational study in a multi-centre, international cohort surveillance study for the detection of hepatitis B virus (HBV) resistance to tenofovir (TDF) in HIV-HBV co-infected patients Status: Opened on Oct 9, 2008. Ongoing. Target/Enrolled: 52/52. Worldwide there is a total of 93 cases Collaborators: Sharon Lewin, Joe Sasadeusz, Jennifer Audsley and Gail Matthews Sites: Australia: e Alfred Hospital, Melbourne, Melbourne Sexual health Centre (MSHC), Melbourne and St Vincents Hospital, Sydney. ailand: ai Red Cross AIDS Research Centre and Department of Medicine, King Chulalongkorn Memorial Hospital, Bangkok Funding: Gilead Science

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Long-term HBV cohort HIV-NAT 105 Long term outcome of HBV in ai cohort of HIV/HBV co-infected patients (Substudy of HIV-NAT 006) is is a long term cohort to assess HBV and HIV treatment outcome, liver brosis, renal function, metabolic syndrome, including vitamin D and Bone health. Status: Opened on Dec 25, 2008. Ongoing. Target/Enrolled: 155/155 Funding: ai Research Fund HBsAg HIV-NAT 105.1 Hepatitis B surface antigen levels in long term therapy of tenofovir in HIV-HBV-coinfected patients is is a cross section study toevaluate the role of quantitative HBsAg in predicting treatment response to HBV. Status: Opened on 4 May 2012 Target/Enrolled: 150/150 Collaborators: Department of Biochemistry, Faculty of Medicine, Chulalongkorn University Funding: Ratchadaphiseksomphot Fund, Faculty of Medicine, Chulalongkorn University FLU002 HIV-NAT 122 An International Observational Study to Characterize Adults with Inuenza A Pandemic H1N1 (H1N1v) INSIGHT H1N1v Outpatient Study (FLU 002) e purpose of this observational study is to describe participants in geographically diverse locations with inuenza A-pandemic H1N1 (H1N1v) virus infection and their clinical course over a 14-day period following enrolment. Status: Opened Jan. 21, 2010. Ongoing Target/Enrolled: unlimited/213 enrolled cases as of 2-Oct-2012 for Chulalongkorn site; 96 enrolled cases as of 2-Oct-2012 for Khon kaen site Collaborators: Division of Infectious Diseases, Department of Medicine, University: Opass Putcharoen, Sarawoot Marklon, Leilani Paitoonpong, Gompol Suwanpimolkul, Voraphoj Nilaratanakul, Nontalee ongsong, Pornvimol Leethong, Paisan Techawaleekul, Suwimon Khusuwan; Khon Kaen University: Ploenchan Chetchotsakd. Enrollment (projected): 1,500 patients in Asia, Europe, Australia, North and South America Sites: Chulalongkorn Hospital and Srinakarind Hospital/Khon Kaen University Funding: National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) and carried out by the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT).

Publication: Surveillance of illness associated with pandemic (H1N1) 2009 virus infection among adults using a global clinical site network approach: e INSIGHT FLU 002 and FLU 003 studies. Vaccine 2011. 29S: B56-B62. FLU 003 HIV-NAT 123 An International Observational Study to Characterize Participants with Inuenza APandemic H1N (H1N1v) Who Are Hospitalized with Complications of Inuenza. INSIGHT H1N1v Inuenza Hospitalization Study. e purpose of this observational study is to describe the characteristics and outcomes over a 60-day follow-up period of participants in geographically diverse locations who develop inuenza A -pandemic H1N1 (H1N1v) and who are hospitalized with complications resulting from inuenza. Status: Opened Jan. 21, 2010. Ongoing Target/Enrolled: unlimited/15 enrolled cases as of Sep-2012 for Chulalongkorn site; 5 enrolled cases for Khon kaen site Collaborators: Division of Infectious Diseases, Department of Medicine,University: Opass Putcharoen, Sarawoot Marklon, Leilani Paitoonpong, Gompol Suwanpimolkul, Voraphoj Nilaratanakul, Nontalee ongsong, Pornvimol Leethong, Paisan Techawaleekul, Suwimon Khusuwan; Khon Kaen University: Ploenchan Chetchotsakd Enrollment (projected): 1,000 patients in Asia, Europe, Australia, North and South America Sites: Chulalongkorn Hospital, Srinakarind Hospital and Khon Kaen University. Funding: National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) and carried out by the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT). HCV HIV-NAT 125 Characteristics and clinical signicances of hepatitis C genotype in HIV-and hepatitis C co-infected ai patients. Status: Opened June 8, 2010. Ongoing Target/Enrolled: 100/100 Funding: Ratchadaphiseksomphot Fund, Faculty of Medicine, Chulalongkorn University, and Oce of the National Research Council of ailand Results: HCV genotype 3 (47%) is predominant circulating HCV genotypes in our HIV/HCV co-infection and HCV mono infection, following by genotype1 (34%) and genotype 6 (18%). High prevalence of HCV genotype 6 was observed (13% HIV/HCV and 18% HCV mono). HCV genotype 6 tended to have higher HCV RNA but lesser liver brosis compared to HCV genotype 1 and 3.

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Approximately, 91% of our patients have favorable IL-28B gene. Factors associated with moderate to severe liver brosis in our HCV patients were HIV-coinfection, HCV genotype 3 and Fib-4 >1.45 Presentation: Avihingsanon A, Mek-A-nantawat W, Apornpong T, Akkarathamrongsin S, Ubolyam S, Chomhong P, Tangkitvanich P. Distribution of HCV genotype and Single Nucleotide Polymorphisms (SNPs) of IL-28B gene in HIV/HCV coinfected ai Populations. [Poster # P132]presented at the International Congress on Drug erapy in HIV. Glasgow, Glasgow, UK. 11-15 November 2012 CMV study HIV-NAT 130 Mortality and Morbidity Risk Factors of Cytomegalovirus Viremia in AIDS Patients Starting Antiretroviral erapy in ailand is is a retrospective observational cohort and nested case-control study. is study will assess the possible association between CMV viremia and increased risk of mortality or the development of AIDS-dening illnesses in patients from HIV-NAT 006 long term cohort. Status: Closed 2012 Target/Enrolled: 600/336 Funding: Abbott

HPV study Prevalence and 6- and 12-month incidence of cervical cytological abnormality and HR-HPV infection in a cohort of HAART nave and HAART experienced women. Status: Completed 2012 Site: e ai Red Cross AIDS Research Center (TRC-ARC) Collaborators: SEARCH, e ai Red Cross AIDS Research Center (TRC-ARC), Vanderbilt University and Amsterdam Institute for Global Health and Development (AIGHD) Funding: Commission of Higher Education, National Research University, HIV-NAT Presentation: Ramautarsing RA, Phanuphak N, Ananworanich J, Sahasrabuddhe V, Lange JMA, Wit F van de Wijgert JH, Pankam T, Rodbamrung , P, Phanuphak P, Triratanachat S, Teeratakulpisarn N, Chaithongwongwatthana S. Anogenital HPV-infection in ai HIV-infected women with high CD4 counts [Poster P32.33] presented at the 27th International Papillomavirus Conference. September 17-22, 2011, Berlin, Germany Results: Manuscript for baseline results has been submitted. Results from 12 months are currently being analyzed. Published: Manuscript has been submitted.

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HPV-019 PRI HIV-NAT 161 A phase IV, observer-blind, randomized, controlled, multicentric study to assess the safety and immunogenicity of GSK Biologicals HPV-16/18 L1 VLP AS04 vaccine (Cervarix) administered intramuscularly according to a three-dose schedule (Day 0, Week 6, Month 6) in human immunodeciency virus-infected (HIV+) female subjects aged 15 25years, as compared to Mercks HPV-6/11/16/18 vaccine (Gardasil)). Status: Opened on June 7, 2011 Target/Enrolled: 30/30 Funding: GlaxoSmithKline HIV-NAT 163 HPV genotypes present in cervical dysplasia and cervical cancer in HIV-infected women e aim of this study is to investigate the HPVgenotype distribution in HIV-infected women with cervical cysplasia or cervical cancer compared to HIV-uninfected women. Stored tissue samples from Chulalongkorn Hospital are used for HPV genotyping. Status: Opened on July 26, 2011. Ongoing Target 100 Collaborators: ai Red Cross AIDS Research Center (TRC-ARC), Chulalongkorn University Funding: Ratchadaphiseksomphot Fund, Faculty of Medicine, Chulalongkorn University IRC 003/HIV-NAT 164 A Randomized Double-Blind Phase 2 Study Comparing the Ecacy, Safety, and Tolerability of Combination Antivirals Versus Standard Treatment for the Treatment of Inuenza in Adults at Risk for Complications is is a multicentered, randomized double-blind phase 2 study that will assess the ecacy, safety, and tolerability of combination antivirals versus the standard treatment for the treatment of inuenza in an at-risk outpatient population.

Status: Opened June 26, 2012. Ongoing. Target/Enrolled: 720 globally; 10 per ai site/5 enrolled patients at Bamrasnadura Infectious Disease Institute site only. Sites: 4 sites in ailand; 48 sites worldwide Collaborators: National Institute of Health (NIH), Bamrasnaradura Infectious Disease Institute, Khon Kaen University, Siriraj Hospital, and the Division of Infectious Diseases,Departmentof Medicine, Faculty of Medicine,Chulalongkorn University Funding: National Institute of Health (NIH) IRC 004/HIV-NAT 165 A Randomized Double-Blind Study Comparing Standard Treatment Versus Placebo for the Treatment of Inuenza in Low Risk Adults is is a randomized blinded study that will evaluate whether the standard treatment modies viral shedding in an ambulatory population with uncomplicated inuenza and explore the relationship between virologic eects and clinical eects, eects on proinammatory mediators, and to start understanding if improve ments to virologic shedding correlate with improvements in clinical outcomes. Status: Opened June 26, 2012. Ongoing. Target/Enrolled: 560 globally; 50 per ai site/1 enrolled case at Chulalongkorn Hospital and 20 enrolled cases at Bamrasnaradura Infectious Disease Institute Sites: 4 sites in ailand; 48 sites worldwide Collaborators: National Institute of Health (NIH), Bamrasnaradura Infectious Disease Institute, Khon Kaen University, Siriraj Hospital and the Division of Infectious Diseases,Departmentof Medicine,Faculty of Medicine,Chulalongkorn University Funding: National Institute of Health (NIH) HPV Vaccine HIV-NAT 177 Evaluation of immunogenicity and safety of the bivalent HPV vaccine in HIV-infected women Status: Recruitment is open Target: 150 women Collaborators: ai Red Cross AIDS Research Center (TRC-ARC), Chulalongkorn University Site: ai Red Cross AIDS Research Center (TRC-ARC) Funding: Ratchadaphiseksomphot Fund, Faculty of Medicine, Chulalongkorn University

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CLINICAL RESEARCH PROGRAMS IN CO-TUBERCULOSIS INFECTIONS

There are three Tuberculosis (TB) studies currently being conducted in adults of which one still needs additional funding. HIV-NAT is currently participating in the TB network. TB studies emerging from the network address issues pertaining to the country with the aim to improve the TB care in the country so that we can reduce TB mortalities by half by 2015 as per the Millenium Development Goals. Working with various Chest Units from the different hospitals have been fruitful in accomplishing this goal.
Optimize TB Treatment outcome in Tertiary Care Hospitals Status: Opened on April 28, 2011. Ongoing Target/Enrolled: 936/336 Site PIs: Bamrasnaradura Infectious Disease Institute: Kamon Kawkitinarong Division of Infectious Diseases, Department of Medicine, Faculty of Medicine, Chulalongkorn University: Opass Puthacharoen Sites: Bamrasnaradura Infectious Disease Institute, Rajvethi Hospital, Chulalongkorn University (ChestUnit, Internal MedicineDepartment, and DivisionofInfectious Diseases, Department of Medicine,ChulalongkornUniversityHospital) Collaborators: Disease Department Control (DDC), ailand Funding: National Research University Grant (NRU) Regional TB Study HIV-NAT 170 Socio-Economic Determinants of Tuberculosis (TB), Multidrug-resistant TB, and Immune Reconstitution Syndrome in HIV-TB Co-infected Patients in Asia Status: Opened April 5, 2012. Ongoing Target/Enrolled: 400/4; 50 at HIV-NAT, 200 for all sites in ailand Funding: e American Foundation for AIDS Research (amfAR), erapeutics Research, Education, and AIDS Training in Asia (Treat Asia)

TB is a major global health problem, a leading cause of death in HIV infected persons and the burden is especially high in Asia and Africa. Successful TB control involves early case detection and diagnosis through quality-assured methodology, provision of safe and ecacious treatment and a system that support quality patient care and supervision. e management of HIV and TB co-infection is further complicated by complex interactions between drugs used to treat both conditions. us HIV-NAT has conducted the following studies. Denise Hsu HIV-NAT 104 is is a pilot study of the pharmacokinetics and safety of lopinavir/ritonavir 400/100mg bid versus lopinavir/ritonavir 600/150 mg BID combined with nucleoside analogue reverse transcriptase inhibitors in HIV/TB co-infected patients receiving rifampicin containing anti-tuberculosis therapy. Status: Opened on March 2, 2011. Ongoing Target/Enrolled: 17/40 Collaborators: David Burger (Radboud UMC Nijmegen, e Netherlands), Kamol Kawkitinarong and Gompol Suwanpimolkul (Infectious Disease, Chulalongkorn University) and Supannee Jirajariyavet (Infectious Disease, Taksin Hospital) Sites: TRC-ARC and Chulalongkorn Hospital Funding: HIV-NAT (additional funds being sought)

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LONG TERM COHORT ANALYSIS

HIV-NAT has one adult long-term cohort (HIV-NAT 006) and pediatric long-term cohort (HIV-NAT 015) studies. From the PREDICT study, one of its substudy is a long-term cohort study (HIV-NAT 035.3; additional information is in the Pediatric section). HIV-NAT also participates in the regions long-term cohorts for both the adults (TAHOD) and paediatrics (TApHOD). HIV-NAT also participates in the collection, maintenance and analysis of Thailands database of HIV infected patients (PROGRESS studies). There is one HPV co-infection cohort study (TNT HIV 003) done with the Thai Red Cross AIDS Research Centre. There are 2 hepatitis co-infection cohorts (additional information located in the Clinical Research Programs in Co-viral and Viral Infections section). In addition, hepatitis C co-infection cohort is being set up as we speak. There are two studies looking at the effects of syphilis and neurocognitive changes among patients from the 006 cohort. Other target population long-term cohorts are in the pipeline.

Long-term cohorts are necessary in order to see the long-term eects of either the drugs and/or infection(s). Most of the studies do not look at long-term eects or over the span of 10 years and hence these cohorts will help elucidate some unanswered questions. Unfortunately the data may be dicult to analyse and compare between studied/analysed groups due to dierent initial regimens or missing data for some of our older patients. However, with time, additional information are collected as we nd out which issues become important but the maintenance of such cohorts are also expensive. HIV-NATs hepatitis co-infection cohort is one of the largest in the world and other types of cohorts targeting dierent populations are in the pipeline.

HIV-NAT 006 is is a long-term, post study cohort of HIVinfected patients who previously participated in HIV-NAT study protocols. Information collected from this cohort will provide further insights into the long-term safety and durability of various antiretroviral therapeutic approaches, ecacy of HIV viral load and CD4 cell counts as predictors of disease progression, mortality, resistance proles, adherence, immune recovery syndrome, opportunistic infections or malignancies, incidence of lipodystrophy, other metabolic complications, cardiovascular, renal, hepatic, and endocrine function, skin, gastrointestinal system and urogenital tract problems and quality of life. Status: Opened May 15, 2007 Target/Enrolled: unlimited/1498

Collaborators: David A. Cooper and Joep MA Lange Funding: HIV-NAT Drug Fund, Division of AIDS Ministry of Public Health (MOPH) ailand, National Health Security Oce (NHSO), Social Security Oce (SSO), e Aligning Care and Prevention of HIV/AIDS with Government Decentralization to Achieve Coverage and Impact: Project (Global fund ailand), Roche, Bristol-Myers Squibb, Merck & Co., Tibotec Pharmaceuticals Ltd., Gilead Science

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Publications: 1) Anal squamous intraepithelial lesions among HIV-positive and HIV-negative men who have sex with men in ailand. Sex Transm Infect. 2009 Dec;85(7):503-7. 2) Nadir CD4 count and monthly income predict cervical squamous cell abnormalities in HIV-positive women in a resource-limited setting. Int J STD AIDS. 2008 Aug;19(8):529-32 3) A prevalence of posttransplantation cancers compared with cancers in people with human immunodeciency virus/acquired immunodeciency syndrome after highly active antiretroviral therapy. Transplant Proc. 2008 Oct;40(8):2677-9. 4) Assessing adherence in ai patients taking HAART. Int J STD AIDS.2012 Mar;23(3):160-5 5) Ecacy and tolerability of zidovudine 200 mg BID as part of combination antiretroviral therapy for 96 weeks. J Acquir Immune Dec Syndr. 2010 Aug 15;54(5):e19-20. 6) Cardiovascular Risk Assessment in Persons with HIV in the Developing World: Comparing ree Risk Equations in a Cohort of HIV-infected ais. HIV Med. 2011 Sep;12(8):510-5. 7) Feasibility and Ecacy of INH prophylaxis for latent tuberculosis in HIV infected Patients in ailand. AIDS Research and Human Retroviruses 2012 Mar;28(3):270-5. 8) Clarke A, Kerr S, Honeybrook A, Cooper DA, AvihingsanonA, Duncombe C,Phanuphak P, Ruxrungtham K, Ananworanich J, Kaldor J. Adherence and Risk Behaviour in Patients with HIV Infection Receiving Antiretroviral erapy in Bangkok. e open virology journal. Open Virol J.2012; 6:23-8. 9) Praditpornsilpa K, Avihingsanon A, Chaiwata-narat T, Chaiyahong P, Wongsabut J, Ubolyam S, Chulakadabba A, Avihingsanon Y, Ruxrungtham K, Tunsanga K, Eiam-Ong S, Phanuphak P. Comparisons between validated estimated glomerular ltration rate (GFR) equations and isotopic GFR in HIV patients. AIDS. 2012 Sep 10;26(14):1781-8. 10) Treatment outcome and safety of zidovudine/ lamivudine/nevirapine xed-dose combination in HIV-infected ai patients. (Submitted) 11) Long term ecacy of Low Dose RitonavirBoosted Atazanavir (200/100 mg) in ai HIV-1 Infected Adults. (Submited) Presentation: Prevalence and prognostic factors of chronic kidney disease in HIV-infected patients, HIV-NAT 006 cohort, ailand. [Poster #: 843] presented at the 18th Conference on Retrovirus and Opportunities Infections (CROI 2011). Boston, MA, USA. 27 February 2 March 2011.

Syphilis Study HIV-NAT 157 Serodiagnosis of syphilis and outcomes of treatment among HIV-infected patients is objective of this study is to determine the prevalence of syphilis in the cohort HIV-NAT 006 study and the outcomes of treatment after 24 and 48 weeks using serological tests. Status: Opened on Feb 17, 2011. Ongoing. Closed to recruitment. Awaiting analysis Enrolled: Phase 1: 1437 cases; Phase 2: 214 cases. Funding: Ratchadaphiseksomphot Fund, Faculty of Medicine, Chulalongkorn University, Presentation: Maek-a-nantawat W, Jamthong J, Laopraynak N, Moonthong K, Ubolyam S, Avihingsanon A. Syphilis and Risk behaviors among HIV-infected individuals on antiretroviral therapy. Poster # 51.008 at the Society for Infectious Diseases, June 13-16, 2012, Bangkok Results: e existence of latent syphilis continued to be prevalent among HIV-infected patients in our cohort.MSMs are at a higher risk of acquiring syphilis and may require more-frequentscreenings for STIs. To prevent STIs, physicians should encourage their patients to consistently andregularly use condoms.Health education and social marketing campaigns urgently need to target groupsat risk to consistently and regularly use condoms. Presentation: Maek-a-nantawat W, Jamthong J, Laopraynak N, Moonthong K, Ubolyam S, Avihingsanon A. Syphilis and Risk behaviors among HIV-infected individuals on antiretroviral therapy. Poster # 51.008 presented at the 15th Inter-national Congress on Infectious Diseases and the International Society for Infectious Diseases, June 13-16, 2012, Bangkok HAND Study HIV-NAT 166 Trialto evaluate neurocognitive functions, neuropsychiatric changes and activities of daily living among HIV infected patients in the Cohort HIV-NAT 006 study is is an observational study among treatment naive or experienced HIV-infected adults who has been deferred, interrupted or initiated the rst line antiretroviral regimens and currently on antiretroviral therapy using self assessed questionnaires about neuropsychiatric changes and daily activities and brief assessment of neurological performance with International HIV dementia scale (IHDS) andMontreal Cognitive Assessment (MoCA). Other tests such as Trial making,EIWA digit symbol task, Grooved pegboard test and block design will also be done. is study will describe the rates of neurocognitive changes among HIV-infected patients in the Cohort 006 study and determine factors related to neurocognitive changes among HIV-infected patients.

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Status: Opened Nov 29, 2011. Ongoing Target/Enrolled: HIV-NAT 006 cohort population/70 Collaborators: Pramongkutklao Hospital and SEARCH Funding: Seeking funding HIV-NAT 015 is is a long-term follow-up study of safety and ecacy of antiretroviral therapy for HIV positive children who have previously participated in HIV-NAT study protocols. Status: Opened on July 8, 2003. Ongoing Target/Enrolled: 500/332 Collaborators: Chitsanu Panchareon, David A. Cooper, Joep MA Lange Site: Chulalongkorn Hospital Funding: e ai National Security Oce (NHSO) and ai Ministry of Public Health, e Aligning Care and Prevention of HIV/AIDS with Government Decentralization to Achieve Coverage and Impact: Project (Global fund ailand) Publications: 1) Pattern and predictors of immunologic recovery in human immunodeciency virus-infected children receiving non-nucleoside reverse transcriptase inhibitor-based highly active antiretroviral therapy. Pediatr Infect Dis J. 2009 Jun;28(6):488-92. 2) Immunologic and virologic failure after rst-line highly active antiretroviral therapy in HIV-infected children. AIDS Res er.2011 Oct 26;8:40. TAHOD: e Treat Asia HIV Observational Database HIV-NAT 048 is study collects observational data on HIV-infected patients from a number of sites in several Asian countries. e information gathered will help develop more eective research and treatment programs for people living with HIV/AIDS in the region. Status: Opened on January 15, 2008. Ongoing. Target/Enrolled: 200/200 Collaborators: Mana Khongpatanayothin and David A. Cooper Collaborator/site: Chulalongkorn Hospital Coordinating Center: National Centre in HIV Epidemiology and Clinical Research, University of New South Wales, Sydney, Australia Funding: Foundation for AIDS Research, United States (amfAR) Publications and Presentations: (Please see Partnerships section for TAHOD) TREAT Asia Pediatric HIV Observational Database (TApHOD) HIV-NAT 080 is study is an HIV pediatric HIV observational database collecting HIV clinical data from 6 countries located in the Asia-Pacic region.

is information will be used to develop more eective research and treatment programs for people with HIV/AIDS in the region. Status: Opened May 3, 2007. Ongoing. Target/Enrolled: 500/302 Funding: Foundation for AIDS Research, United States (amfAR) Publications and Presentations: (Please see Partnerships section for TApHOD) TNT-HIV 003 is is a ve-year prospective cohort study that investigates the trends of morbidity and mortality among ai HIV-infected and HIVuninfected patients. is study has one substudy, TNT-HIV 003.1, which assesses the bone health and vitamin D status in HIV-1 infected and uninfected adults. Status: Started in Oct. 2010. Ongoing and open to recruitment Target/Enrolled: Group 1 (HIV infected):408/242; Group 2 (HIV uninfected):408/266 Site PIs: e ai Red Cross AIDS Research Centre: Praphan Phanuphak Bamrasnaradura Infectious Disease Institute: Wisit Prasithisirikul Queen Savang Vadhana Memorial Hospital: Tanate Jadwattanakul Collaborators: Peter Reiss and Ferdinand Wit, Amsterdam Institute for Global Health and Development (AIGHD) Funding: e ai Red Cross AIDS Research Centre and ViiV Healthcare ere is one substudy looking at vitamin D and bone health (TNT-HIV 003.1). is substudy is currently open to recruitment and enrollment is ongoing. ere are three groups: 1. HIV infected, 2. HIV infected with HIV CD4, and 3. HIV infected naives planning to start HAART. Enrolled: Group1: 70; Group 2: 55; Group 3: 65. e Progress (Adult cohort) HIV-NAT 153 e ai HIV Disease Progression: An Observational Database is is a multicenter, observational prospective cohort study open cohort that will study the HIV disease progression in HIV-infected ai Adult. Status: Opened on March 8, 2011. Ongoing Target/Enrolled: 7000/5000 Site PIs: Bamrasnaradura Infectious Disease Institute: Wisit Prasithsirikul San Patong Hospital: Virat Klinbuayaem Sites: Bamrasnaradura Infectious Disease Institute, San Patong Hospital and HIV-NAT Collaborators: Department Disease Control (DDC), ailand Funding: Department Disease Control (DDC), ailand

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Pediatric Progress HIV-NAT 154 e ai Pediatric HIV Disease Progression: An Observational Database e objective of this cohort is to describe the multicenter cohort of HIV-infected children in ailand Status: Opened on March 8, 2011. Ongoing Target/Enrolled: 1,500 HIV-infected children from 4 sites/1139 Site: Chiangrai Prachanukroh Hospital, Sanpatong Hospital, Faculty of Medicine, Siriraj Hospital, Mahidol University Collaborators: Oce of the National Research Council of ailand, and Bamrasnaradura Infectious Diseases Institute, Nonthaburi Funding: Department Disease Control (DDC), ailand Presentations: Poster number 43.023 in 15th International Congress on Infectious Diseases (ICID), 13-16 June 2012, Bangkok, ailand

STRATEGY STUDIES
There are 5 strategic studies with 14 substudies, all of which are done with the Kirby Institute except for the feasibility study. One study looks at when is the optimal time to start ART based on CD4 count. Two studies look at reduced dosage versus standard dose. One study evaluates the use of second regimen amongst those patients who have developed drug resistant HIV strains whereas another study investigates the feasibility of the concept Test and Treat among the MSM population in Bangkok. Encores neurocognitive substudy was initiated by HIV-NAT.

Strategic studies aim to change the treatment guidelines by addressing research gaps or changing how we currently care for the patients. ere are several unanswered questions and research gaps especially in the developing countries such as aging in HIV infected population and management of noncommunicable diseases (i.e., cancer, renal, pulmonary, neurocognitive and mental health). We are slowly trying to address all of these questions as permitted by the available human and nancial resources. START (Strategic Timing of AntiRetroviral Treatment) HIVNAT 097 A Multicenter Study of the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) e purpose of this randomized study is to determine whether immediate initiation of antiretroviral treatment (ART) is superior to

deferral of ART until the CD4+ declines below 350 cells/mm3 in terms of morbidity and mortality in HIV-1infected persons who are antiretroviral naive with a CD4+ count above 500 cells/mm3. e study will proceed in two phases: (1) a pilot phase, involving at least 900 participants; and (2) a denitive phase, expanding enrollment to an estimated 4,000 participants. Upon completion of the pilot phase, a recommendation will be made to the sponsor (DAIDS, NIAID, NIH) concerning whether the study should be expanded and prolonged into a denitive study. Successful completion of the pilot phase requires enrollment of at least 900 participants in one year by 70 designated INSIGHT sites. For ailand, seven additional sites were included: Siriraj Hospital, San Patong Hospital, Chonburi Hospital, Chiangrai Prachanukroh Hospital, RIHES Chiang Mai Univer- sity, Ramathibodi Hospital and Bamrasnaradura Infectious Disease Institute

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Status: Opened on June 25, 2009. Ongoing. Target/Enrolled: 65/88 HIV-NAT site; 250/166 ailand Collaborators: Chulalongkorn University, Ploenchan Chetchotisakd (Srinagarind Hospital, Khon Kaen University), Chonburi Regional Hospital. Siriraj Hospital, Mahidol University, Chiangrai Prachanukroh Hospital, Sanpatong Hospital, Bamrasnaradura Infectious Disease Institute, Ramathibodhi Hospital, Mahidol University, Research Institute for Health Sciences (RIHES), Chiang Mai University Site PIs: Srinagarind Hospital, Khon Kaen University: Ploenchan Chetchotisakd Siriraj Hospital: anomsak Anekthananon San Patong Hospital: Virat Klinbuayaem Chonburi Hospital: Chureeratana Bowonwatanuwong Chiangrai Prachanukroh Hospital: Pacharee Kantipong RIHES Chiang Mai University: Khuanchai Supparatpinyo Ramathibodi Hospital: Sasisopin Kiertiburanakul Bamrasnaradura Infectious Disease Institute: Wisit Prasithsirikul Sponsor: e National Institute of Allergy and Infectious Diseases (NIAID) Division of AIDS (DAIDS) National Institutes of Health (NIH) Publication: START; design considerations for a large simple trial to examine the time to commence antiretroviral therapy for the treatment of HIV infection. J Clin Trials 2011. In press. ere are 10 substudies of which8 are still ongoing: 1. Arterial Elasticity : Closed enrolment 2. Pulmonary 3. Bone Mineral Density 4. Fibrosis Progression 5. Consent 6. Genomic 7. Tissue biopsy for cancer in the future 8. Storage sample (blood and urine) 9. Neuro : Closed enrolment 10. Monitoring ENCORE1 (Evaluation of Novel Concepts in Optimization of antiRetroviral Ecacy) HIVNAT 128 A randomized, double-blind, placebo-controlled, clinical trial to compare the safety and ecacy of reduced dose (400mg) efavirenz (EFV) with standard dose EFV plus two nucleotide reverse transcriptase inhibitors (N(t)RTI) in antiretroviral-naive HIV-infected individuals over 96 weeks. HIV-NAT is the ai co-ordinating centre. ere are three substudies: 1) CNS, 2) Intensive PK and 3) Neurocognitive substudy. Sta from HIV-NAT have

initiated this last substudy and will be responsible for the data collection and sub-study analysis. Status: Opened June 17, 2010. Closed to recruitment. Ongoing. Target/Enrolled: 120/122 ailand Collaborators: Ploenchan Chetchotisakd (Srinagarind Hospital, Khon Kaen University) and Khuanchai Supparatpinyo (Research Institute for Health Sciences (RIHES), Chiang Mai University) Sites: is study will involve 51 sites in 17 countries. ree sites in ailand. Sponsor: e Kirby Institute for Infection and Immunity in Society, University of New South Wales (UNSW), Sydney, Australia) and Bill & Melinda Gates Foundation ere are 3 substudies of which all are still ongoing in parallel with the main sudy: PK substudy HIV-NAT 128.1 A randomised, double-blind, placebo-controlled, clinical trial to compare the safety and ecacy of reduced dose efavirenz (EFV) with standard dose EFV plus 2N(t)RTI in antiretroviral-nave HIV-infected individuals over 96 weeks Encore1 intensive pharmacokinetics sub-study Status: Completed 2012 Target/Enrolled: 10/10 Collaborators: Chelsea and Westminster Hospital, London, UK; Hospital J.M. Ramos Mejia, Buenos Aires, ARGENTINA; Desmond Tutu HIV Foundation, Cape Town, SOUTH AFRICA; ai Red Cross-AIDS Research Centre, HIV-NAT Research Collaboration, Bangkok, ailand Funding: e Kirby Institute for Infection and Immunity in Society, University of New South Wales (UNSW), Sydney, Australia) CNS substudy HIV-NAT 128.2 A randomised, double-blind, placebo-controlled, clinical trial to compare the safety and ecacy of reduced dose efavirenz (EFV) with standard dose EFV plus 2N(t)RTI in antiretroviral-nave HIV-infected individuals over 96 weeks. Neurocognitive substudy HIV-NAT 128.3 e neurocognitive sub-study in Encore1: A randomised, double-blind, placebo-controlled, clinical trial to compare the safety and ecacy of reduced dose efavirenz (EFV) with standard dose EFV plus 2N(t)RTI in antiretroviral-nave HIV-infected individuals over 96 weeks

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SECONDLINE (A randomized open-label study comparing the safety and ecacy of ritonavir boosted lopinavir and 2-3N(t)RTI backbone versus ritonavir boosted lopinavir and raltegravir in participants virologically failing rst-line NNRTI/2N(t)RTI therapy: the SECOND-LINE study) HIVNAT 119 is is a Phase IIIb/IV, international, randomized, open label study comparing two regimens of combination antiretroviral therapy in people living with HIV with conrmed virological failure of rst-line NNRTI/2N(t)RTI regimens. e study runs for 96 weeks but the primary analysis takes place at the week 48. Status: March 11, 2010. Closed to recruitment. Ongoing. Target/Enrolled: 100/67 ailand Collaborators: Ploenchan Chetchotisakd (Srinagarind Hospital, Khon Kaen University), Niramon Leeratanapetch (Khon Kaen Hospital), Khuanchai Supparatpinyo (Research Institute for

HIV-infected adults Status: Opened on Oct 29, 2010. Ongoing Target/ Enrolled: 100/68 HIV-NAT ; 560/300 ailand Collaborators: Wisit Prasithsirikul, Ploenchan Chetchotisakd, Chureeratana Bowonwattanuwong, Patcharee Kantipong, Sasisopin Kiertiburanakul, Virat Klinbuayaem, Supunnee Jirajariyavej, Warangkana Munsakul, Niramon Leerattanapetch, Siritorn Nimitvilai, Sukit Bunjongkit, Malee Techapornroog and Supavadee Tongsakulrungraeng Protocol Shadow Team: Alli Humphries, Stephen Kerr, and Mark Boyd Mentors: David Cooper and Sean Emery Sites: Bamrasnaradura Infectious Disease Institute, Khon Kaen University, Chonburi Hospital, Chiang Rai Prachanukroh Hospital, Ramathibodi Hospital, Sanpatong Hospital, Taksin Hospital, and Vajira Hospital, University of Bangkok Metropolitan Administration, Khon Kaen Hospital, Nakornpathom Hospital, Rayong Hospital Prapokklao Hospital, Pranangklao Hospital

Health Sciences (RIHES), Chiang Mai University) Sites: Approximately 50 sites from Australia, Africa, Asia, Latin America, and Europe. Four sites in ailand Sponsor: e Kirby Institute for Infection and Immunity in Society, University of New South Wales (UNSW), Sydney, Australia ere is one substudy: 1. Bone and Body Comp: A sub study of SECOND-LINE study LASA (Low dose Atazanavir/r vs. Standard dose Atazanavir/r) HIVNAT 110 A multicenter randomized study to compare the ecacy and safety of lower dose atazanavir/ ritonavir (ATV/r 200/100 mg OD) versus standard dose (ATV/r 300/100 mg OD) in combination with 2NRTIs in well virology suppressed

Funding: NHSO and e Kirby Institute for Infection and Immunity in Society, University of New South Wales (UNSW), Sydney, Australia Presentation: Bencharat T, Chavalun R, Mark B, Peeraporn K, Chalandakorn R, Alli H, Wipada C, Anchalee A, Kiat R, Torsak Bon behalf of LASA study team. Acceptability of web-based electronic data capture in a multicentre randomized trial in ailand. [Poster #265] presented at Australian HIV/AIDS Conference 2012 24th Annual Conference of the Australian Society for HIV Medicine, Melbourne, Australia. 17-19 October 2012

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LASA HAIR substudy HIV-NAT 110.2 is study will evaluate the atazanavir/ritonavir concentration in hair Status: Oct. 25, 2011. Ongoing Target/Enrolled: 400/193 Feasibility Study (Test and Treat) HIV-NAT 162 Trialto Evaluate the Acceptability and Feasibility of Test and Treat and link-to-care to reduce HIV transmission among men having sex with menin Bangkok

is cross-sectional study will evaluate the interest and attitudes on regular voluntary HIV counseling and testing, assess the acceptability of immediate antiretroviral therapy if seropositive and identify the associated factors in improving access to treatment and care. e information from this study will be used to design the upcoming Test and Treat Study. Status: Opened on July 14, 2011. Ongoing Target/ Enrolled: 400/363 Collaborators: ai Red Cross Anonymous Clinic Sites: ai Red Cross MSM Clinic, ai Red Cross Mobile Clinic Funding: HIV-NAT

NEW DRUG DEVELOPMENT

There are 8 studies investigating new drugs, 2 of which are conducted in children. Two studies were completed this year. All of these studies also investigated the pharmacokinetics, safety and efcacy of the new drugs. Two of the studies are conducted in nave adults and one in experienced adult. One study evaluated the different doses while the other study was done in treatment stable patients. Few patients are required for the pharma studies which have many sites world wide but a much more stringent recruitment/enrollment timeline. HIV-NAT has completed 5 feasibility studies.

From 100 new HIV drugs, this number has been reduced to 60 as of 2012. On August 28, 2012, Stribild or formerly known as the QUAD pill, composed of four drugs (Elvitegravir/cobicisat/ emtricitabine/tenofovir) was approved by the US FDA for once a day administration. However, elvitegravir and cobicistat are not approved for use individually and are awaiting US FDA approval at

the time this went to press. Cobicistat, like ritonavir, is a pharmacokinetic booster but on its own has no HIV activity whereas elvitegravir is a new integrase inhibitor. Further developments for three new compounds (vicriviroc(a CCR5 inhibitor), GSK-761 (an NNRTI), andbevirimat(a maturation inhibitor)) have been discontinued. Other compounds are currently being investigated in phase 2-3 trials. As there are many compounds, we have picked a few of them that we have found exciting to mention: Rilpivirine (TMC-278), S/GSK1349572, Bevirimat (PA457 or MPC-4326) and Vivecon (MPC9055). Rilpivirine is a second-generation nonnucleoside reverse transcriptase inhibitor (nonnuke or NNRTI) to be administered once daily with Truvada as a xed dose combination (FDC) tablet. S/GSK 1349572 is a next generation integrase inhibitor that does not need to be administered with a booster. Bevirimat (PA457 or MPC-4326) and Vivecon (MPC 9055) are new drugs from a new class of drugs known as the maturation inhibitor. Many pharmaceutical companies are now develo-ping FDCs which can be administered once daily which will denitely help improve the patients adherence and quality of life.

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THRIVE (http://clinicaltrials.gov/ct2/show/NCT00543725) HIV-NAT 091 A Phase III, randomized, double-blind trial of TMC278 25 mg q.d. versus efavirenz 600 mg q.d. in com-bination with a background regimen consisting 2 nucleoside/nucleotide reverse transcriptase inhibitors in antiretroviral-nave HIV-1 infected subjects Status: Closed June 2012 Target/Enrolled: 20/18 Funding: Tibotec Pharmaceuticals Ltd. TMC125-TiDP2-C238 (http://clinicaltrials.gov/ct2/show/NCT00896051) HIV-NAT 137 A randomized, exploratory, open-label 48-week trial with a 2-week Pre-Treatment Phase to investigate the pharmacokinetics, safety, tolerability and antiviral activity of etravirine (ETR) in combination with ritonavir-boosted atazanavir (ATV/rtv) and 1 NRTI in treatment-experienced HIV-1 infected subjects Status: Closed 2012 Target/Enrolled: 6/3 Funding: Tibotec Pharmaceuticals Ltd. GS-US-216-0114 (http://clinicaltrials.gov/ct2/show/NCT01108510? term=GS-US-216-0114&rank=1) HIV-NAT 138 is is a multicenter phase 3, randomized, double-blind, active-controlled study to evaluate the safety and ecacy of a regimen containing GS-9350-boosted atazanavir (ATV/GS-9350) versus ritonavir-boosted atazanavir (ATV/r) each administered with emtricitabine/tenofovir disoproxil fumarate (Truvada, FTC/TDF) in HIV-1 infected, antiretroviral treatment-nave adult subjects. Status: Opened Sept 2, 2010. Ongoing Enrolled: 14 Funding: Gilead Sciences PRINCE 1 (http://clinicaltrials.gov/ct2/show/NCT01099579? term=PRINCE+1&rank=1) HIV-NAT 143 A Prospective Single Arm, Open-label, International, Multicenter Study to Evaluate the Safety, Ecacy and Pharmacokinetics of Atazanavir (ATV) Powder Boosted with Ritonavir (RTV) Liquid with an Optimized NRTI Background erapy, in HIV Infected Pediatric Patients Greater an or Equal to 3 Months to Less an 6 Years; Pediatric Atazanavir International Clinical Evaluation: the PRINCE I study (AI424397) is study will evaluate the pharmacokinetic and ecacy data of atazanavir/r in HIV-infected children.

Status: Opened on April 7, 2011. Ongoing Target/Enrolled: 1/1 Funding: Bristol-Myers Squibb BMS - AI467003 (http://clinicaltrials.gov/ct2/show/NCT01489046) HIV-NAT144 A Phase IIb Randomized, Controlled, Partially Blinded Clinical Trial to Investigate the Safety, Ecacy and Dose-response of BMS-986001 in Treatment-naive HIV-1-infected Subjects, Followed by an open-label Period on the Recommended Dose. Status: Opened on May 2012. Ongoing Target/Enrolled: 25/21 Funding: Bristol-Myers Squibb (BMS) TMC278-TiDP6-C222 (http://apps.who.int/trialsearch/trial aspx? trialid= EUCTR2010-021209-18-IT) HIV-NAT 150 An open-label trial with TMC278 25mg q.d. in combination with a background regimen containing 2nucleoside/nucleotide reverse transcriptase inhibitors in HIV-1infected subjects, who participated in TMC278clinical trials. Status: Opened on June 7, 2011. Ongoing Target/Enrolled: 13/13 Funding: Tibotec Pharmaceuticals Ltd. HIV-NAT 156 (http://clinicaltrials.gov/ct2/show/NCT00791700? term=maraviroc+AND+children&rank=1) An open-label, multicenter, multiple-dose pharmacokinetic, safety and ecacy trial of maraviroc in combination with optimized background therapy for the treatment of antiretrovival-experienced CCR-5 tropic HIV-1 infected children 2-<18 e study will evaluate the ecacy and safety of maraviroc in HIV-infected children. Status: Opened on Feb 3, 2011. Ongoing Target/Enrolled: 2/1 Funding: ViiV Healthcare MARCH study http://clinicaltrials.gov/ct2/show/NCT01384682? term=the+kirby+institute&rank=11) HIV-NAT 169 A randomised, open label study to evaluate the ecacy and safety of maraviroc (MVC) as a switch for either nucleoside or nucleotide analogue reverse transcriptase inhibitors (N(t)RTI) or boosted protease inhibitors (PI/r) in HIV 1 infected individuals with stable, well controlled plasma HIV RNA while taking their rst N(t)RTI + PI/r regimen of combination antiretroviral therapy (cART)) Status: Opened on May 31, 2012- Ongoing Target/Enrolled: 15/8 Funding: University of New South Wales, Kirby institute

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SEXUAL HEALTH
HIV-NAT has never had any sexual health studies until two years ago: HIV-NAT 114 and HIV-NAT 126. Since then, more sexual health studies are taking place. This year, there are four sexual health studies and one substudy. One study was completed in 2011 and two studies were completed this year, including one substudy. Two more studies are pending IRB approval at the time this was written. More sexual health studies designed by the nurses are in the pipeline.

For several years HIV-NAT has been conducting research in the eld of sexual health. Every man and woman has a right to sexual health. In the context of HIV, proper sexual health can contribute to the vertical and horizontal prevention of transmission of the infection. We have completed studies on the sexual life of HIV-positive heterosexual men and women, on their intention for conception and options for contraception, as well as on menopause in HIV-positive women. Currently we are evaluating dierent contraceptive methods, including the uptake and continuation of use of intrauterine devices in HIV-positive women, and pharmacokinetic interactions between selected antiretrovirals and combined hormonal contraception. We are also working with particular target groups of interest such as serodiscordant couples, and in 2013 we plan to begin research with adolescents. by Nadia Kancheva Landolt HIV MENQOL HIV-NAT 117 is is a cross-sectional study which evaluates the quality of life and menopausal related symptoms in ai HIV infected women aged 40 years and older (HIV MENQOL cross sectional study). Target/Enrolled: 300/300 Status: Closed Feb 2012 Site: Pramongkutklao Hospital of the Royal ai Army Funding: Chulalongkorn University (Ratchadapiseksompoch Grant) Presentatation: Age at Menopause and Menopausal-related Symptoms in ai HIV-infected Women. [Poster #: P_34] presented at the 1st International Workshop on HIV & Women, from adolescent through menopause. Washington D.C., USA. 10-11 January 2011 Results: Age at menopause in HIV-infected ai women was 47.3 years, which is signicantly earlier than the ndings of a previous report on non-HIV-infected women. Postmenopausal HIVinfected women had more vasomotor and sexual symptoms. Published: Boonyanurak P, Bunupuradah T, Wilawan K, Loeanyod A, ongpaeng P, Chatvong D, Sophonphan J, Saeloo S, Ananworanich J,

Chaithongwongwatthana S. Age at menopause and menopausal-related symptoms in ai HIVinfected women. Menopause: e Journal of e North American Menopause Society 2012: 19 (7) Preventive study in reproductive health and HIV HIV-NAT 126 Contraception and the prevention of HIV infection - conception and contraception in ai people living with HIV is is a cross-sectional study with two stages: stage 1 questionnaire; stage 2 focus group discussion. e main goal is to assess sex practices, contraceptive methods used and the desire for conception in ai PLH via administering a questionnaire and conducting focus group discussions. Target/Enrolled: 200/200 Status: Completed in March 2011. Publication: Landolt NK,Phanuphak N,Pinyakorn S,Lakhonphon S,Khongpetch C,Chaithongwongwatthana S,Ananworanich J. Sexuallife,optionsforcontraceptionand intentionforconceptioninHIV-positivepeople onsuccessfulantiretroviraltherapyin ailand. AIDS Care.2012;24(7):897-904. ere is one substudy: HIV-NAT 126.1 Intrauterine Device as a modern method of contraception in ai HIV-positive women is is a prospective study with a follow up period of six months. e main goal is to assess the acceptance of and adherence to intrauterine device (IUD) as a contraceptive method in ai HIVpositive women. Target/Enrolled: 100/29 Status: Closed 2012 Funding: Ratchadaphiseksomphot Fund, Faculty of Medicine, Chulalongkorn University, and HIV-NAT Results: Copper IUD, though currently not a common choice among ai HIV-positive women, could be accepted. Education on IUD risks and benets is needed to promote the use of IUD in addition to condoms as an eective contraceptive option in HIV-infected women. Published: Manuscript has been submitted and awaiting results

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Pharmacokinetic hormonal study HIV-NAT 147 Pharmacokinetic interactions between sex steroid hormones and NNRTIs in HIV-positive ai Women Status: Closed on Dec 2, 2011; blood levels of sex steroid hormones in process Target: 60 Enrolled 68 Funding: Ratchadaphiseksomphot Fund, Faculty of Medicine, Chulalongkorn University, and HIV-NAT Results: In contrast to NVP, co-administrating DSG/EE containing COC, with EFV was associated with unfavorable progesterone and ARV levels. Our results suggest that NVP may be superior to EFV when used with COC in HIV positive women.

Published: First manuscript submitted to journal. Second manuscript is foreseen once sex steroid hormones laboratory results are ready. Serodiscordant Couple HIV-NAT 168 Reproductive health and HIV Characterize HIV serodiscordance in heterosexual couples Status: Opened on June 12, 2012, ongoing Target/Enrolled: 300 sero-discordant couples approximately Collaborators: e ai Red Cross Anonymous Clinic Funding: Ratchadaphiseksomphot Fund, Faculty of Medicine, Chulalongkorn University, and HIV-NAT

OTHERS
In keeping with HIV-NATs desire to expand into other elds of study, currently there are 7 studies looking at various issues ranging from asthma to immunology to adherence. All of the studies are currently ongoing. One of the study looks at asthma while two investigate the immune response and another surveillancing HIV drug resistance and its new recombinant forms. One study examines voluntary counselling and testing (VCT) among MSMs whereas two other studies investigate adherence in adolescents and TB co-infected patients respectively. Other studies are being developed with experts from the geriatric, psychiatric and molecular biology departments as well as community non-governmental organizations (NGOs).

HIV-NAT is interested in other areas of study and is always looking for collaborators and/or partners to share this with. However, HIV-NAT also understands the need to prioritize its work so each year, certain areas are chosen to be further investigated. ere are many ideas for studies but for now, only those studies that can address the current needs of HIV-NAT patients and ailand will be put into motion. Asthma Children with HIV and Asthma (CHIVAS) HIV-NAT 102 Allergen specic T eector and T regulatory cell response to common aeroallergens following immune restoration in HIV-infected children is aims to study allergen specic T eector and T regulatory cell response in HIV-infected children before and after commencement of HAART. Status: Opened on March 26, 2009. Ongoing Target/Enrolled: 20/8 Mentors: William T. Shearer (Baylor College of Medicine, TX, USA) and Pantipa Chatchatee

(Division of Allergy & Immunology, Department of Pediatrics, the King Chulalongkorn Memorial Hospital, Chulalongkorn University, Bangkok) Site: HIV-NAT, the ai Red Cross AIDS Research Centre and the King Chulalongkorn Memorial Hospital Funding: CU Cluster RatchadapisekSompotch Endowment Fund, Chulalongkorn University

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Immunology studies CD4+poor response HIV-NAT 132 Prevalence, factors and immunopathogenesis of inappropriate immune reconstitution (CD4+ below 200 cells/mm3) in ai patients with long term viral suppression following antiretroviral therapy. is is a retrospective, observational study that addresses why some HIV patients have CD4 <200 copies/mm3 despite being on ART and have viral load <50 copies/mL. is study will assess the factors contributing to this phenomenon and how these patients dier compared to those with CD4 <200 copies/mm3. Status: Opened on May 27, 2010. Ongoing Target/Enrolled: 50/50 Funding: Ratchadaphiseksomphot Fund, Faculty of Medicine, Chulalongkorn University Restore study HIV-NAT 136 is is a prospective, observational study to explore reconstitution of immunity in patients with advanced HIV-1-infection commencing combination antiretroviral therapy. e protocol is designed to mirror standard of care (SOC) visits for this patient population. e main dierence to SOC is the formal collection of data and the collection of extra blood volumes. Four-year study Status: Opened on Sept. 2, 2010. Closed to recruitment. Continuing to follow patients. Week 96 follow up has been completed in Oct 2012. Target/Enrolled: 50/53 Funding: e Kirby Institute for Infection and Immunity in Society, University of New South Wales (UNSW), Sydney, Australia Results: e CD25/CD134assayshowed good agreement with QFN-GIT I ndetectingrecall responseto TB both in well and less resourced setting as well as in persons with advanced HIV infection. Published: Hsu DC, Zaunders JJ, Plit M, Leeman C, Ip S, Lampornsin T, Pett SL, Bailey M, Amin J,

Ubolyam S, Avihingsanon A, Ananworanich J, Ruxrungtham K, Cooper DA, Kelleher AD. A novel assay detecting recall response to Mycobacterium tuberculosis: Comparison with existing assays. Tuberculosis (Edinb). 2012 Jul;92(4):321-7 MSM VCT HIV-NAT 148 Multidisciplinary services to enhance HIV testing and linkage to care among MSM is is a prospective cohort study which will determine the impact of MSM-targeted multidisciplinary services on uptake of HIV voluntary counseling and testing (VCT) and enrollment into care and retention of HIV-positive MSM. Status: Opened on March 3, 2011. Ongoing Target/Enrolled: 200 HIV-negative and 150 HIV- positive MSM participants Sites: TRC Anonymous Clinic, Sanglah Hospital, Bali, Indonesia and Cipto Mangunkusumo Hospital, Jakarta, Indonesia Funding: e National Institute of Health (NIH)/ Presidents Emergency Fund for AIDS Relief (PEPFAR) Supplement, ai Red Cross AIDS Research Centre and HIV-NAT Results: complete study at site Jakarta and Bali , during monitoring at site TRC Published: plan data analysis in November and manuscript writing in December 2012 Drug Resistance HIV Drug Resistance Study HIV-NAT 158 Surveillance of HIV resistance transmission and new HIV recombinant forms in ailand Status: Opened May 24, 2011 Target/Enrolled: 160/103 Collaborators: e ai Red Cross AIDS Research Centre; Srinagarind Hospital, ailand; Chonburi Hospital, ailand; Chiangrai Prachanukroh Hospital, ailand; Suratthanee Hospital, ailand; Queen Savang Vadhana Memorial Hospital, ailand Funding: National Research Universities

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Adherence study TApHOD ACASI HIV-NAT 155 e objective of this study is to collect information on adherence and behavioral risk factors in HIV-infected adolescents who are being followed in the TApHOD cohort study. Status: Opened on April 28, 2011. Closed to recruitment. Target/Enrolled: 50/50 Site: Chiangrai Prachanukroh Regional Hospital, ailand; HIV-NAT, ailand; Kuala Lumpur Hospital Pediatric Institute, Malaysia; Hospital Likas, Malaysia; Hospital Raja Perempuan Zainab II, Malaysia Funding: e American Foundation for AIDS Research (amfAR), erapeutics Research, Education and AIDS Training in Asia (Treat Asia) Results: e percentages of Asian HIV-infected adolescents in this pilot study reporting risk-taking behaviors, adherence problems, or having experienced stigmatization and violence were generally low, appropriate psychosocial interventions are needed to prevent and address these issues in HIV-infected adolescents aging into adulthood.

Presentatation: Risk Behaviors and Treatment Adherence among HIV-infected Adolescents in the TREAT Asia Pediatric HIV Observational Database. [Poster# P 18] the International Workshop on HIV Pediatrics 2012. Washington D.C., USA 20-21 July 2012 Questionnaire study Adherence, associated factors and interventions (TB questionnaire study) HIV-NAT173 Causes of discontinuity of tuberculosis treatment and strategies to improve the treatment outcomes of tuberculosis in University Hospital e objective of this study is survey of tuberculosis in Bangkok will begin university hospital and new patient to nd of cause of absence of drug and loss follow up of treatment in the Chulalongkorn hospital, for the reect problem of tuberculosis in the big cities. Status: Opened on Aug 7, 2012. Start Enrollment Nov 2012 Target/Enrolled: 1300/0 Funding: Chulalongkorn University (Ratchadaphiseksomphot Endowment Fund)

PEDIATRIC AND YOUTH RESEARCH PROGRAMS

There are 22 ongoing pediatric and youth studies (14 HIV-NAT initiated, 4 collaborator-initiated, and 4 sponsor-initiated study). We also have more studies in adolescent including adherence project and HPV vaccination. We are having more publications from PREDICT substudies and early 2013 we will have result of PEARL study.

Even though our knowledge in the eld of pediatric HIV has been increasing, yet there are still many unanswered questions because HIV treatment in infants and children diers from adults. New pediatric formulations continue to be lacking. Long-term eects of various drugs such as tenofovir are unknown.As these children grow older and become teenagers, other problems such as adherence and sexual trans mitted infections become important. Drug resistance and eects that alter the basic blood prole such as increase in triglycerides and cholesterol are a constant battle among pediatricians taking care of these patients. Pediatric HIV continues to be challenging but fullling as we learn more about it.

PREDICT (Paediatric Randomized to Early vs Deferred Initiation in Cambodia and T hailand) HIV-NAT 035 is is an open label, randomized phase III study comparing early versus deferred (starting HAART when CD4+ falls below 15%) initiation of HAART in anti-retroviral-naive children aged one to 12 years with CDC paediatric clinical classication category A or B and CD4+ between 15 to 24%. (NCT 00234091) Status: Completed in 2011 Enrolled: 180 ai/120 Cambodian children Site PIs in ailand: Bamrasnaradura Infectious Disease Institute: Jurai Wongsawat , Khon Kaen University: Pope Kosalaraksa, Queen Savang

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Vadhana Memorial Hospital: Wicharn Luesomboon, Nakornping Hospital: Suparat Kanjanavanit, Chiangrai Regional Hospital: Rawiwan Hansudewechakul, and Prapokklao Chantaburi: Chaiwat Ngampiyasakul Site PIs in Cambodia: National Center for HIV/AIDS, Dermatology and STDs (NCHADS): Mean Chhi Vun and Vonthanak Saphonn Collaborator: David A. Cooper Funding: National Institute of Allergy and Infectious Diseases (NIAID): Comprehensive International Program of Research on AIDS (CIPRA) grant. Antiretroviral medication is provided at no cost by GlaxoSmithKline (AZT, 3TC and Abacavir), Boehringer Ingelheim (nevirapine), Merck (efavirenz), Abbott (lopinavir/ritonavir) and Homann La Roche (nelnavir). Publications: 1. Lessons from a multicentre paediatric HIV trial. Lancet. 2008 Aug 2;372(9636):356-7. 2. CD4 Cell Count Criteria to Determine When to Initiate Antiretroviral erapy in Human Immunodeciency Virus-Infected Children. Pediatr Infect Dis J.Oct;29(10):966-8 3. Ananworanich J,Apornpong T,Kosalaraksa P, Jaimulwong T,Hansudewechakul R,Pancharoen C, Bunupuradah T,Chandara M, Puthanakit T, Ngampiyasakul C,Wongsawat J,Kanjanavanit S, Luesomboon W, Klangsinsirikul P,Ngo-GiangHuong N,Kerr SJ, Ubolyam S, Mengthaisong T, Gelman RS,Pattanapanyasat K,Saphonn V, Ruxrungtham K,Shearer WT;PREDICT Study Group. Characteristics oflymphocyte subsetsin HIV-infected, long-term nonprogressor, and healthy Asian children through 12years of age. J Allergy Clin Immunol.2010 Dec;126(6):1294-301 4. High prevalence of lipid abnormalities among Antiretroviral-naive HIV-infected Asian children with mild to moderate immunosuppression. Antiviral erapy. 2011;16(8):1351-5 5. Poor quality of life among untreated ai and Cambodian children without severe HIV symptoms. AIDS care. 2012;24(1):30-8. 6. Puthanakit T, Saphonn V, Ananworanich J, Kosalaraksa P, Hansudewechakul R, Vibol U, Kerr SJ, Kanjanavanit S, Ngampiyaskul C, Wongsawat J, Luesomboon W, Ngo-Giang-Huong N, Chettra K, Cheunyam T, Suwarnlerk T, Ubolyam S, Shearer WT, Paul R, Mofenson LM, Fox L, Law MG, Cooper DA, Phanuphak P, Vun MC, Ruxrungtham K; on behalf of the PREDICT Study Group. Early versus deferred antiretroviral therapy for children older than 1 year infected with HIV (PREDICT): a multicentre, randomised, open-label trial. Lancet Infect Dis. 2012 Oct 8. pii: S1473-3099(12)70242-6. 7. Puthanakit T, Bunupuradah T, Kosalaraksa P, Vibol U, Hansudewechakul R, Ubolyam S, Suwanlerk T, Kanjanavanit S, Ngampiyaskul C, Wongsa-

wat J, Luesomboon W, Vonthanak S, Ananworanich J, Ruxrungtham K. Prevalence of HLA-B*5701 among HIV-Infected Children in ailand and Cambodia: Implications for Abacavir Use. Pediatr Infect Dis J. 2012 Sep 17. 8. Bunupuradah T, Ubolyam S, Hansudewechakul R, Kosalaraksa P, Ngampiyaskul C, Kanjanavanit S, Wongsawat J, Luesomboon W, Pinyakorn S, Kerr S, Ananworanich J, Chomtho S, van der Lugt J, Luplertlop N, Ruxrungtham K,Puthanakit T; PREDICT study group. Correlation of selenium and zinc levels to antiretroviral treatment outcomes in ai HIV-infected children without severe HIV symptoms. Eur J Clin Nutr. 2012 Aug;66(8):900-5. 9. Kanjanavanit S,Puthanakit T, Vibol U, Kosalaraksa P, Hansudewechakul R, Ngampiyasakul C, Wongsawat J, Luesomboon W, Wongsabut J, Mahanontharit A, Suwanlerk T, Saphonn V, Ananworanich J, Ruxrungtham K; PREDICT study group. High prevalence of lipid abnormalities among antiretroviral-naive HIV-infected Asian children with mild-to-moderate immunosuppression. Antivir er. 2011;16(8):1351-5. Presentations: 1) Five-year experience in ailand of using CLIA and ISO to establish a laboratory network for US NIAID Pediatric Clinical Trials. [CD Rom Abstract # CDD278] presented at the 6th IAS Conference on HIV Pathogenesis, Treatment and Prevention. 17-20 July 2011. Rome, Italy. 2) Improved in iron status and anemia in HIVinfected children after zidovudine-containing HAART without routine iron supplementation. [poster # MOPE255] presented at the 6th IAS Conference on HIV Pathogenesis, Treatment and Prevention. 17-20 July 2011. Rome, Italy. 3) Incidence and risk factors for nevirapine related toxicities among HIV-infected Asian children randomized to starting ART at dierent CD4%. [Poster # MOPE240] presented at the 6th IAS Conference on HIV Pathogenesis, Treatment and Prevention. 17-20 July 2011. Rome, Italy. 4) Randomized clinical trial of immediate versus deferred antiretroviral therapy initiation in children older than one year with moderate immunodeciency: e PREDICT Study (NCT00234091). [Poster # LBPE023; abstract # TULBPE023] presented at the 6th IAS Conference on HIV Pathogenesis, Treatment and Prevention. 17-20 July 2011. Rome, Italy. 5) Impact of Selenium and Zinc level on antiretroviral treatment outcomes in ai HIVinfected children. [Poster # P_29]* presented at 3rd International Workshop on HIV Pediatrics. 15 - 16 July 2011, Rome, Italy and 6th IAS Conference on HIV Pathogenesis, Treatment and Prevention. 17-20 July 2011. Rome, Italy.

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ere are substudies for PREDICT 1) HIV-NAT 035.1: is sub study assesses the eect of immediate versus deferred antiretroviral initiation on neurodevelopment in children with HIV in Cambodia and ailand. Neurodevelopment is assessed every six months. e primary outcome is the neurodevelopment functions in the immediate arm compared to the deferred arm at week 144. Status: Closed in 2011 Enrolled: 180 ai/120 Cambodian children Funding: National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Mental Health (NIMH), National Institute of Child Development (NICHD). 2) Micronutrient/HIV-NAT 035.2: is sub-study assesses the impact of selenium/zinc levels on HIV disease and treatment response in children. Status: Closed 2011 Enrolled: 180 ai Funding: National Institute of Allergy and Infectious Diseases (NIAID) 3) PREDICT sub study- PREDICT Cohort HIV-NAT 035.3 Extension for HIV-NAT 035 Status: Feb 20, 2007. Close May 2014. Target/Enrolled: 300/283 Site PIs in ailand: Bamrasnaradura Infectious Disease Institute: Jurai Wongsawat, Khon Kaen University: Pope Kosalaraksa, Queen Savang Vadhana Memorial Hospital: Wicharn Luesomboon, Nakornping Hospital: Suparat Kanjanavanit, Chiangrai Prachanukroh Hospital: Rawiwan Hansudewechakul, and Prapokklao Chantaburi: Chaiwat Ngampiyasakul. Site PIs in Cambodia: National Center for HIV/ AIDS, Dermatology and STDs (NCHADS): Mean Chhi Vun and Vonthanak Saphonn Collaborator: David A. Cooper Funding: National Research Council of ailand 4) PREDICT Neuro Control group/ HIV-NAT 035.4 e neurodevelopment in normal children in Cambodia and ailand Status: Opened Oct 26, 2010 Target/Enrolled: 300/300 PENTA 11 HIV-NAT 066 is is a long term follow-up study assessing whether children with HIV infection undergoing planned ART interruptions are disadvantaged clinically, immunologically, virologically or neurologically from periods of time o ART. Status: Opened on Oct. 6, 2005. Ongoing until May 2013 Target/Enrolled: 9/9 Funding: Pediatric European Network for Treatment of AIDS (PENTA)

Publication: 1. Response to planned treatment interruptions in HIV infection varies across childhood. AIDS (London, England). 2010 Jan 16;24(2):231-41 2. Adherence to Antiretroviral erapy and Acceptability of Planned Treatment Interruptions in HIV-Infected Children. AIDS and Behavior 2012 May 15 3. Outcomes after reinitiating antiretroviral therapy in children randomized to planned treatment interruptions in the PENTA 11 Study. Accepted by AIDS 2012 HIV-NAT 080.3 Treatment response of chronic viral hepatitis B to tenofovir and lamivudine-containing antiretroviral regimen in HIV-infected adolescents with chronic hepatitis B co-infection; HBV-HIV adolescent cohort is study will investigate the treatment of HBV-co infection in HIV-infected children. Status: Opened on Dec. 15, 2011. Ongoing Target/Enrolled: 3/0 Sites: Chiangrai Prachanukroh Hospital, Srinagarind Hospital, Khon Kaen University; Nakornping Hospital, Research Institute for Health Sciences and Chiang Mai University Funding: amfAR, Treat Asia HIV-NAT 090 An Open-label Study of Liquid and Sprinkled Formulations of Efavirenz Administered in Combination with Didanosine and Emtricitabine in HIV-infected Infants and Children 3 months to 6 years of Age (AI266922) is study will evaluate the pharmacokinetic and ecacy of efavirenz in HIV-infected children. Status: Closed 2012

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Target/Enrolled: 1/1 Funding: Bristol-Myers Squibb Publications: in JAIDS review PAINT (TMC 278-C213) HIV-NAT 099 is is a phase II, open label, single arm multicenter trial evaluating the pharmacokinetics, safety, tolerability and antiviral activity of Rilpivirine (TMC 278-C213) in naive HIV-infected adolescents between the ages of 12 and 18 years. Status: Opened on Jan. 29, 2009. Ongoing Target/Enrolled: 1/1 Funding: Tibotec Pharmaceuticals HIV-NAT 109 Meaning of life in ai HIV infected youth is is a randomized control trial. is study will evaluate the eect of logotherapy in HIV infected youths. Status: Opened on Nov 17, 2010. Ongoing Target/Enrolled: 48/23 Collaborator: Arunya Tuicomepee (Counseling Psychology Program, Faculty of Psychology, Chulalongkorn University) Funding: Art AIDS Fund PIANO (TMC125-C213) HIV-NAT 112 is is a phase II, open-label multicenter trial evaluating the safety, tolerability and antiviral activity of Etravirine (TMC 125-C213) in treatment experienced HIV-infected children and adolescents. Status: Closed 2012 Target/Enrolled: 7/7 Funding: Tibotec Pharmaceuticals ird line HAART in HIV-infected children HIV-NAT 113 is study will assess ecacy and safety of third line regimen in 150 ai children. Status: Opened on August 17, 2010. Ongoing Target/Enrolled: 150/56

Site PIs in ailand: Kulkanya Chokephaibulkit, Jurai Wongsawat, Rawiwan Hansudewechakul, Pope Kosalaraksa, Suparat Kanjanavanit, Chaiwat Ngampiyakul, Pakarat Sangkla Collaborators/sites: Chulalongkorn Hospital, Siriraj Hospital, Bamrasnaradura Infectious Disease Institute, Chiang Rai Regional Hospital, Srinagarind Hospital Khon Kean University, Nakornping Hospital, Prapokklao Hospital and Surin Hospital Funding: Commission of Higher Education (CHE) Presentation: Pharmacokinetics of darunavir/ ritonavir in Asian HIV-1 infected children aged 6 years. [Poster #714] presented at the 18th Conference on Retrovirus and Opportunities Infections (CROI 2011). Boston, MA, USA. 27 February 2 March 2011. 2. Ananworanich J, Prasitsuebsai W, Kosalaraksa P, Kanjanavanit S, Ngampiyaskul C, Wongsawat J, Sangkla P, Suwarnlerk T, Sophonphan J, Hansudewechakul R, Wittawatmongkol O, Puthanakit T, Chokephaibulkit K. Outcomes of third-line antiretroviral therapy containing darunavir, etravirine or raltegravir in ai children with HIV infection. Presented at XIXInternational AIDS Conference, Washington DC, USA. July 22-27, 2012 MRI brain in Children HIV-NAT 121 is is a prospective study that will compare the total brain volume between HIV-infected and healthy children by using multimodal imaging approach such as tensor-based morphometry (TBM) and diusion tensor imaging (DTI). Status: Ongoing Enrolled/Target: 105/150 Collaborators: Pope Kosalaraksa, Linda Aurpibul, Sukalaya Lerdlum, Victor Valcour, Paul ompson and Robert Paul Sites: SEARCH, Khon Kaen University, Chulalongkorn University, Research Institute for Health Sciences (RIHES), Chiang Mai University, University of California at San Francisco, University of Missouri and University of California at Los Angeles Funding: National Institutes of Health KONCERT/PENTA 18 HIV-NAT 124 A Kaletra ONCE daily Randomized Trial of the pharmacokinetics, safety and ecacy of twice-daily versus once-daily lopinavir/ritonavir tablets dosed by weight as part of combination antiretroviral therapy in HIV-1 infected children is study will evaluate once daily lopinavir/ ritonavir-based HAART in virological suppressed children. Status: Opened on July 15, 2010. Ongoing Target/Enrolled: 8/8 Funding: Paediatric European Network for Treatment of AIDS (PENTA)

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HIV-NAT 133 e objective of this study is to determine the ecacy of TDF-based regimen in HIV-infected ai children and assess eect of TDF on renal problem and bone mineral density. Status: Opened on Dec. 16, 2010. Ongoing Target/Enrolled: 36/35 Funding: National Research Council of ailand HPV Study HIV-NAT 139 e objectives of this study is to compare the prevalence of HPV infection among perinatally HIV-infected adolescents, behaviorally HIV-infected adolescents, and HIV-negative adolescents, and compare the prevalence of intraepithelial neoplasia and presence of E6/E7 biomarker at cervical and anal sites among perinatally HIV-infected adolescents, behaviorally HIV-infected adolescents, and HIV-negative adolescents. Status: Opened on Dec 2, 2010. Closed to recruitment. Ongoing Target/Enrolled: 81/100 Sites: HIV-NAT, Petchburi Hospital, Siriraj Hospital and ChiangraiPrachanukroh Hospital Funding: e American Foundation for AIDS Research (amfAR), erapeutics Research, Education and AIDS Training in Asia (Treat Asia) Results: At least one-third of perinatally and behaviorally HIV-infected adolescents had abnormal cytology and at least half had HPV infection and E6/E7 oncogenic mRNA. HIV positive adolescents need access to preventative HPV immunization and routine monitoring for pre-cancerous and cancerous changes. Presentation: Ananworanich J, Prasitsuebsai W, Kerr SJ, Phasomsap C, Pankam T, Rodbamrung P, Teeratakulpisarn N, Petdachai W, Sohn, Phanuphak N on behalf of the HIV-NAT 139 Study Group. Prevalence of Cervical and Anal HPV Infection and Intraepithelial Neoplasia Biomarkers in Perinatally and Behaviorally HIV-Infected Compared to HIV-Negative Adolescents. [Poster # S-147] presented at the 19th Conference on Retrovirus and Opportunities Infections (CROI 2012). Seattle, WA USA. March 5-8, 2012. BREATHER/PENTA 16 HIV-NAT 140 Short-Cycle erapy (SCT) (5 days on/2 days o) in young people with chronic HIV-infection is study will evaluate the ecacy and safety of short cycle therapy in HIV-infected children. Status: Opened on Sept. 16, 2010. Ongoing Target/Enrolled: 20/18 Funding: Paediatric European Network for Treatment of AIDS (PENTA)

TASER-P HIV-NAT 149 TASER-Pediatrics: Prospective Monitoring of Second-line Antiretroviral erapy Failure and Resistance in Children Status: Opened on Feb 3, 2011. Ongoing. Target/Enrolled: 300/264 Collaborators: HIV-NAT, Cipto Mangunkusumo General Hospital, Research Institute for Health Sciences, Chiang Mai University, Srinagarind Hospital. Khon Kaen University, Faculty of Medicine Siriraj Hospital, Mahidol University, University of California San Francisco (UCSF), National Centre in HIV Epidemiology and Clinical Research, University of New South Wales, National Hospital of Pediatrics (Benh vien Nhi Trung Uong), Childrens Hospital Number 1, Childrens Hospital Number 2 Funding: Foundation for AIDS Research, United States (amfAR)/TREAT Asia e PEARL study HIV-NAT 152 Pediatric study for Appropriate dose of Ritonavir boosted Lopinavir in ai HIV-infected children is is a multicenter randomized study to compare the safety and ecacy of low-dose versus standard dose lopinavir/ritonavir containing HAART regimen in virological suppressed HIV-infected ai children. Status: Opened on May 24, 2011. Ongoing. Target/Enrolled: 200/200 Sites: total 11 sites (HIV-NAT, ai Red Cross AIDS Research Center, Bamrasnaradura Infectious Disease Institute, Khon Kaen University, Nakornping Hospital, Prapokklao Hospital, Queen Sirikit National Institute of Child Health, Surin Hospital, Sappasitthiprasong Hospital, Udonthani Hospital, Buddhachinaraj Hospital, Phrachomklao Hospital Funding: National Research Council of ailand and the Government Pharmaceutical Organization Improving Adherence in Adolescents HIV-NAT 171 Randomised Trial Comparing Two Interventions to Improve Adherence to Combination Antiretroviral erapy (cART) in Adolescents and Young Adults with HIV in ailand Status: Opened on 24 July 2012 Target/Enrolled: 110/91 Collaborators: HIV-NAT, SEARCH children and youth program, We Understand Group, Khon Kaen University and AID Access Chiang Rai Site: HIV-NAT, khon Kaen University, Phrachomklao Hospital, Petchaburi, Chaing Rai; Mae Chan Hospital, Phan Hospital, Mae Suai Hospital, Mae Sai Hospital, Phraya Meng Rai Hospital, Somdej Phra Yanna Sangworn Hospital and oeng Hospital Funding: UNICEF ailand and TREAT Asia

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HIV-NAT TEAMS

MEDICAL DEPARTMENT Left to right: Dr. Wasana Prasitsuebsai (Pediatrician, Allergist and Immunologist), Dr. Anchalee Avihingsanon (Head of HIV-NAT physicians and adult infectious disease specialist), Tawan Mengthaisong (MD Coordinator), Piraporn Ohata (MD Assistant), Prof. Kiat Ruxrungtham (Deputy Director of HIV-NAT and of ai Red Cross AIDS Research Centre), Assist. Prof. Wirach Maek-a-nantawat (Internist, Allergy and Immunology Specialist), Dr. Torsak Bunupuradah (Pediatrician, Allergist and Immunologist), Prof. Emer. Praphan Phanuphak (Co-director of HIV-NAT, Director of ai Red Cross AIDS Research Centre), Assoc. Prof. Jintanat Ananworanich (Deputy Director in Scientic Aairs at HIV-NAT), Dr. Denise Hsu (Adult Clinical Trial Physician), Chatsuda Auchieng (Grant Management), Dr. Reshmie Ramautarsing (Adult Clinical Trial Physician), Dr. Louise Tomlins (Adult Clinical Trial Physician)

Dr. Eugene Kroon Missing: Dr. Susie Dunachie

Dr. Nicolas Durier

Dr. Annette Sohn

Dr. Nadia Kanchava Landolt

LABORATORY DEPARTMENT Left to right: atri Iampornsin (Scientist), Apicha Mahanontharit (Laboratory Quality Manager), Narukjaporn ammajaruk (Pharmacologist), Phantipa Onsam-ang (Laboratory Secretary), itiporn Somjit (Assistant Medical Technologist), Sasiwimol Ubolyam (Laboratory Manager), Patcharee Pararit (Assistant Medical Technologist), Patcharin Eamyoung (Medical Technologist), Dr. Denise Hsu (Adult Clinical Trial Physician), Bunruan Sopa (Medical Technologist), Umaporn Chobkarching (Scientist), Mattiga Pingthaisong (Assistant Medical Technologist), Kannika Khlungklang (Assistant Medical Technologist), Tanyathip Jaimulwong (Medical Technologist), Akekalak Khadnanta (Medical Technologist), Channuwat Bouko (Medical Technologist) Missing : Meena Detchaiyasak (Pharmacologist)

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HIV-NAT TEAMS

RESEARCH NURSE DEPARTMENT Left to right: Chonticha Rodchuea (Adult Clinical Research Nurse), Augchara Suwannawut (Secretary), idarat Cuprasitrut (Adult Clinical Research Nurse), ongsuai Chuanjaroen (Pediatric Clinical Research Nurse), Prachya Chaiyahong (Adult Clinical Research Nurse), Chuleeporn Wongvoranet (Adult Clinical Research Nurse), Amornrat Srimuan (Pediatric Clinical Research Nurse), Jaravee Jamthong (Adult Clinical Research Nurse), Sasirat Rakcharoenporn (Adult Clinical Research Nurse), Supalak Phonphithak (Head of Nursing Department), anaporn Mansawat (Assistant Research Nurse), Chompoonoot Sirikum (Pediatric Clinical Research Nurse), Parawee ongpaeng (Adult Clinical Research Nurse), Wanida iansanguankul (Adult Clinical Research Nurse), Nongyao Saysombut (Adult Clinical Research Nurse), Duangjai Chatvong (Administrator), Saowaluk Suksawek (Assistant Research Nurse), Siwanart ammasala (Assistant Research Nurse) Missing : Paristaporn Sarachat (Assistant Research Nurse), Khuanruan Moonthong (Assistant Research Nurse)

CLINICAL RESEARCH ASSOCIATE Left to right: Kanchana Pruksakaew (Clinical Research Associate), Tulathip Suwanlerk (Head of Clinical Research Associate), Suwapit Prasertthanawut (Assistant Clinical Research Associate), idarat Jupimai (Clinical Research Associate), Oratai Butterworth (Junior Clinical Research Associate), Rommanee Anujit (Assistant Clinical Research Associate), Patsamon Rerksirikul (Assistant Clinical Research Associate), Saytiya Tongdaikly (Junior Clinical Research Associate), Kanlaya Charoentonpuban (Clinical Research Associate), Chanya Karapuks (Study Coordinator), Kanittha Pongjit (Junior Clinical Research Associate), Jintana Intasan (Clinical Research Associate) Missing : Peeraporn Kaew-on (Clinical Research Associate), Kanitta Pussadee (Clinical Research Associate), Purivis Chart (Clinical Research Associate), Chalandakorn Ruengprasertkit (Clinical Research Associate)

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HIV-NAT TEAMS

ADMINISTRATIVE DEPARTMENT Left to right: Pornwinit Sattayamongkol (Web Programmer), Dararin Choomsai Na Ayuthaya (Communication Specialist), Praneet Pinklow (Training Coordinator), Jeerakan Janhom (HR Coordinator & Oce Operation Head), Adisak Jamrasrak (Purchaser), Ruksina Chumchure (Administrator), Natthapa Pitayanon (Assistant HR Coordinator) Left to right: Apinya Phuttajitpunt (Housekeeper), Sommai Sattong (Housekeeper), Yodying Kittimakorn (Housekeeper)

BIOSTATISTICS DEPARTMENT Left to right: Suteeraporn Pinyakorn (Biostatistician), Siriwan Keadpudsa (Biostatistician), Jiratchaya Sophonphan (Biostatistician), Stephen Kerr (Head of Biostatistics), Tanakorn Apornpong (Biostatistician), Sirinya Teeraananchai (Biostatistician), Taweesak Channgam (Biostatistician)

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HIV-NAT TEAMS

IT & DATA MANAGEMENT DEPARTMENT Left to right: Chowalit Phadungphon (Database Developer), Tanakorn Sritha (IT Help Desk), Patcharaporn Chusut (Clinical Data Associate), Orathai Chaiya (Junior Clinical Data Associate), Kittimuk Sansuk (IT Engineer), Prapon Koita (Database Programmer), Preecha Moopimon (IT Manager), Chavalun Ruengpanyathip (IT&Data Management Manager), Noppong Hirunwadee (Clinical Data Associate Supervisor), Ormrudee Rit-im (Senior Clinical Data Associate), Wanchai ongsee (Data Entry), Bencharat ongpunchang (Clinical Data Associate), eeradej Boonmangum (Clinical Data Associate) Missing : Wipada Chanthaweethip (Clinical Data Associate)

PHARMACY DEPARTMENT Left to right: Niti Wongthai (Stock Controller), Parinya Sutheerasak (Pharmacist), Plengsri Lertarom (Head of Pharmacy), reepol Sattong (Pharmacist Assistant), Chulalak Sriheara (Pharmacist), Anuntaya Uanithirat (Pharmacist) Missing : Ratree Longcharoen (Pharmacist Assistant), Sarapol Tongphan (Pharmacist Assistant)

FINANCIAL DEPARTMENT Left to right: Duangmanee Seedam (Finance Assistant), Umaporn Methanggool (Accountant), Chornarin angjitthanom (Accountant), Kesdao Nanthapisal (Financial Controller), Kanokon Sirichumpa (Finance Assistant)

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PUBLICATIONS & WRITINGS

As of early September 2012, a total of 43 manuscripts have been accepted for publication and 18 manuscripts are under review. This year there are more publications in relatively a short time compared to last year. The reason for this is because the publication plan are periodically updated and followed to ensure that the manuscript is done according to the set timeframe and works are prioritized. This year, ten international grants and 21 Thai grants were submitted. Only eight international and five Thai grants were awarded.

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For Year 2012

Journal Lancet Infectious Diseases AIDS International Journal of Epidemiology Antimicrobial Agents and Chemotherapy Journal of Acquired Immune Deficiency Syndromes Antiviral Therapy Journal of North American Menopause Society HIV Medicine Expert Opinion on Pharmacotherapy AIDS and Behavior Pediatric Infectious Disease Journal Journal of Medical Virology Tuberculosis Journal of Neurovirology AIDS Research and Human Retroviruses AIDS Research and Therapy Journal of the International AIDS Society Health Education & Behavior AIDS Care European Journal of Clinical Nutrition HIV Clinical Trials Intervirology Microbiology and Immunology Future virology Journal of the Association of Nurses in AIDS Care International Journal of STD & AIDS AIDS Research and Treatment Journal of Clinical Trials Open Virology Journal Total Publications 1 1 1 1 2 5 1 1 1 1 2 2 1 1 4 2 1 1 3 2 1 1 1 1 1 1 2 1 1 43 mean IF Impact Factor 16.144 6.245 5.759 4.672 4.262 3.774 3.758 3.575 3.205 3.195 3.064 2.895 2.65 2.31 2.082 1.77 1.76 1.742 1.539 2.563 1.835 1.756 1.227 1.2 1.090 1.082 0 0 0 2.95

2012 PUBLICATIONS
Bunupuradah T, Pinyakorn S, Puthanakit T. Prevalence of selenium deficiency in Thai HIV-infected children without severe HIV symptoms. Eur J Clin Nutr. 2012 Aug 29. doi: 10.1038/ejcn.2012.116. [Epub ahead of print] No abstract available. Zhou J, Tanuma J, Chaiwarith R, Lee CK, Law MG, Kumarasamy N, Phanuphak P, Chen YM, Kiertiburanakul S, Zhang F Vonthanak S, Ditangco R, Pujari S, Choi JY, , Parwati Merati T, Yunihastuti E, Li PC, Kamarulzaman A, Nguyen VK, Thuy Pham TT, Lim PL. Loss to Followup in HIV-Infected Patients from Asia-Pacific Region: Results from TAHOD. AIDS Research and Treatment 2012;2012:375217. Epub 2012 Feb 22. Chokephaibulkit K, Prasitsuebsai W, Wittawatmongkol O, Gorowara M, Phongsamart W, Sophonphan J, Kerr SJ, Vanprapar N, Puthanakit T, Pasomsap C, Suwanlerk T, Sekar V, Burger D, Ananworanich J; the HIV-NAT 113 Pharmacokinetic Study Group. Pharmacokinetics of darunavir/ritonavir in AsianHIV-1 infected children aged 7 years. Antiviral Therapy 2012 Sep 6 Puthanakit T, Vonthanak S, Ananworanich J, Kosalaraksa P, Hansudewechakul R, Vibol U, Kerr SJ, Kanjanavanit S, Ngampiyaskul C, Wongsawat J, Luesomboon W, Ngo-Giang-Huong N, Chettra K, Cheunyam T, Suwarnlerk T, Ubolyam S, Shearer WT, Paul R, Mofenson LM, Fox L, Law MG, Cooper DA, Phanuphak P, Vun MC, Ruxrungtham K, on behalf of the PREDICT Study Group. Early versus deferred antiretroviral therapy for HIV-infected children older than one year of age: PREDICT - a randomised study. Lancet Infectious 2012 In Press Bunupuradah T, Chetchotisakd P, Jirajariyavej S, Valcour V, Bowonwattanuwong C, Munsakul W, Klinbuayaem V, Prasithsirikul W, Sophonphan J, Mahanontharit A, Hirschel B, Bhakeecheep S, Ruxrungtham K, Ananworanich J on behalf of HIV STAR study group. Neurocognitive Impairment in Patients Randomized to Second-line Lopinavir/ ritonavir-based Antiretroviral Therapy vs. Lopinavir/ ritonavir Monotherapy. Journal For Neurovirology. 2012 In Press

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Tangkijvanich P, Sa-nguanmoo P, Avihingsanon A, Ruxrungtham K, Poovorawan K, Poovorawan Y. Characterization of Hepatitis B Virus Mutations in Untreated Co-infected Patients with HIV and HBV Based on Complete Genome Sequencing. Journal of Medical Virology. 2012 In press Puthanakit T, Bunupuradah T, Kosalaraksa P, Vibol U, Hansudewechakul R, Ubolyam S, Suwanlerk T, Kanjanavanit S, Ngampiyaskul C, Wongsawat J, Luesomboon W, Vonthanak S, Ananworanich J, Ruxrungtham K on behalf of the PREDICT study group. Prevalence of HLA-B*5701 among HIV-infected children in Thailand and Cambodia: implications for abacavir use. Pediatric Infectious Disease Journal. 2012 In Press Puthanakit T, Saksawad R, Bunupuradah T, Wittawatmongkol O, Chuanjaroen T, Ubolyam S, Chaiwatanarat T, Nakavachara P, Maleesatharn A, Chokephaibulkit K. Prevalence and risk factors of low bone mineral density among perinatally HIV-infected Thai adolescents receiving antiretroviral therapy. Journal of Acquired Immune Deficiency Syndromes. 2012 In Press Ramautarsing RA, van der Lugt J, Gorowara M, Sophonphan J, Ananworanich J, Lange JMA, Burger DM, Phanuphak P, Ruxthungtham K, Avihingsanon A. Pharmacokinetics and 48 week safety and efficacy of generic lopinavir/ritonavir in Thai HIV-infected patients. Short Communication. Antiviral Therapy 2012 In Press. Permpalung N, Putcharoen O, Avihingsanon A and Ruxrungtham K. Treatment of HIV Infection with Once-Daily Regimens. Expert Opinion on Pharmacotherapy. 2012 In Press Bunupuradah T, Chetchotisakd P, Ananworanich J, Munsakul W, Jirajariyavej S, Kantipong P, Prasithsirikul W, Sungkanuparph S, Bowonwatanuwong C, Klinbuayaem V, Kerr SJ, Sophonphan J, Bhakeecheep S, Hirschel B, Ruxrungtham K; the HIV STAR Study Group. A randomized comparison of second-line lopinavir /ritonavir monotherapy vs. tenofovir/lamivudine/lopinavir /ritonavir in patients failing NNRTI-regimens: the HIV STAR study. Antiviral Therapy 2012 Jul 2

Kosalaraksa P, Bunupuradah T, Vonthanak S, Wiangnon S, Hansudewechakul R, Vibol U, Kanchanawanit S, Ngampiyaskul C, Wongsawat J, Luesomboon W, Lumbiganon P, Sopa B, Apornpong T, Chuenyam T, Cooper DA, Ruxrungtham K, Ananworanich J, Puthanakit T. Prevalence of anemia and underlying iron status in nave antiretroviral therapy HIV-infected children with moderate immune suppression. AIDS Research and Human Retroviruses In Press 2012 Babiker A, Emery S et al. START; design considerations for a large simple trial to examine the time to commence antiretroviral therapy for the treatment of HIV infection. Journal of Clinical Trials 2012 Avihingsanon A, van der Lugt J, Singphore U, Gorowara M, Boyd M, Ananworanich J, Phanuphak P, Burger D, Ruxrungtham K. Pharmacokinetics and 48 Week Efficacy of Adjusted Dose Indinavir/Ritonavir in Rifampicin-Treated HIV/Tuberculosis-Coinfected Patients: A Pilot Study. AIDS Research and Human Retroviruses. 2012 Mar 6 Chokephaibulkit K, Prasitsuebsai W, Wittawatmongkol O, Gorowara M, Phongsamart W, Sophonphan J, Kerr SJ, Vanprapar N, Puthanakit T, Pasomsap C, Suwanlerk T, Sekar V, Burger D, Ananworanich J on behalf of the HIV-NAT 113 Pharmacokinetic Study Group. Pharmacokinetics of darunavir/ritonavir in Asian HIV-1 infected children aged 7 years. Antiviral Therapy In Press 2012 Puthanakit T, Jourdain G, Suntarattiwong P, Chokephaibulkit K, Siangphoe U, Suwanlerk T, Prasitsuebsai W, Sirisanthana V, Kosalaraksa P, Petdachai W, Hansudewechakul R, Waranawat N, Ananworanich J on behalf of the HIV-NAT 086 study team. High virologic response rate after second-line boosted protease inhibitor-based antiretroviral therapy regimens in children from a resource limited setting. AIDS Research and Therapy 2012 Jun 18;9(1):20. Boonyanurak P, Bunupuradah T, Wilawan K, Loeanyod A, Thongpaeng P, Chatvong D, Sophonphan J, Saeloo S, Ananworanich J, Chaithongwongwatthana S. Age at menopause and menopausal-related symptoms in Thai HIV-infected women. Menopause: The Journal of The North American Menopause Society 2012: 19 (7) Koken JA, Naar-King S, Umasa S, Parsons JT, Saengcharnchai P, Phanuphak P, Rongkavilit C. A Cross-Cultural Three-Step Process Model for Assessing Motivational Interviewing Treatment Fidelity in Thailand. Health Education & Behavior 2012 Jan 6. Ramautarsing RA, van der Lugt J, Gorowara M, Wongsabut J, Khongpetch C, Phanuphak P, Ananworanich J, Lange JMA, Burger DM, Ruxrungtham K, Avihingsanon A. Neither branded nor generic lopinavir/ ritonavir produces adequate lopinavir concentrations at a reduced dose of 200/50 mg BID. Journal of Acquired Immune Deficiency Syndromes 2012 Jan 1;59(1):55-58

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Bunupuradah T, Puthanakit T, Kosalaraksa P, Kerr SJ, Kariminia A, Hansudewechakul R, Kanjanavanit S, Ngampiyaskul C, Wongsawat J, Luesomboon W, Chuenyam T, Saphonn V, Vun M C, Vibol U, Vannary B, Ruxrungtham K, Ananworanich J and on behalf of the PREDICT study group. Poor quality of life among untreated Thai and Cambodian children without severe HIV symptoms. AIDS Care. 2012;24(1):30-8 Lim PL, Zhou J, Ditangco RA, Law MG, Sirisanthana T, Kumarasamy N, Chen YM, Phanuphak P, Lee CK, Saphonn V, Oka S, Zhang F Choi JY, Pujari S, , Kamaru lzaman A, Li PC, Merati TP, Yunihastuti E, Messerschmidt L, Sungkanuparph S; TREAT Asia HIV Observational Database. Failure to prescribe pneumocystis prophylaxis is associated with increased mortality, even in the cART era: results from the Treat Asia HIV observational database. Journal of the International AIDS Society 2012 Jan 26;15:1

Winston A, Puls R, Kerr SJ, Duncombe C, Li PCK, Gill JM, Taylor-Robinson SD, Emery S, Cooper DA for the ALTAIR Study Group. Dynamics of cognitive change in HIV infected individuals commencing three different antiretroviral regimens; a randomised, controlled study. HIV Medicine 2012 Apr;13(4):245-51 Nguyen HL,Ruxrungtham K,Delaugerre C. Genetic Barrier to the Development of Resistance to Integrase Inhibitors in HIV-1 Subtypes CRF01_AE and B. Intervirology. 2012;55(4):287-95 Ananworanich J,Gorowara M,Avihingsanon A,Kerr SJ,van Heesch N,Khongpetch C,Uanithirat A,Hill A,Ruxrungtham K,Burger DM;HIV-NAT 127 Study Team. Pharmacokinetics of and short-term virologic response to low-dose 400-milligram once-daily raltegravir maintenance therapy. Antimicrobial Agents and Chemotherapy 2012 Apr;56(4):1892-8

Hamers RL, Oyomopito R, Kityo C, Phanuphak P, Siwale M, Sungkanuparph S, Conradie F Kumarasamy , N, Botes ME, Sirisanthana T, Abdallah S, Li PC, Ngorima N, Kantipong P, Osibogun A, Lee CK, Stevens WS, Kamarulzaman A, Derdelinckx I, Chen YM, Schuurman R, Vugt MV, Rinke de Wit TF; on behalf of the PharmAccess African (PASER) and TREAT Asia (TASER) Studies to Evaluate Resistance. Cohort Profile: The PharmAccess African (PASER-M) and the TREAT Asia (TASER-M) Monitoring Studies to Evaluate Resistance--HIV drug resistance in sub-Saharan Africa and the Asia-Pacific. International Journal of Epidemiology 2012 Feb;41(1):43-54 Khongphatthanayothin M, Avihingsanon A, Teerata-kulpisarn N, Phanuphak N, Buajoom R, Suwanmala P, Phanuphak P. Feasibility and Efficacy of INH prophylaxis for latent tuberculosis in HIV infected Patients in Thailand. AIDS Research and Human Retroviruses 2012 Mar;28(3):270-5

Le Nguyen H,Pitakpolrat P,Sirivichayakul S, Delaugerre C,Ruxrungtham K. Minority HIV-1 resistant variants in recent infection and in patients who failed first-line antiretroviral therapy with no detectable resistance-associated mutations in Thailand. Journal of Medical Virology 2012 May;84(5):713-20 Harrison L, Ananworanich J, Hamadache D, Compagnucci A, Penazzato M, Bunupuradah T, Mazza A, Ramos JT, Flynn J, Rampon O, Mellado Pena MJ, Floret D, Marczynska M, Puga A, Forcat S, Riault Y, Lallemant M, Castro H, Gibb DM, Giaquinto C; On Behalf of the Paediatric European Network for Treatment of AIDS (PENTA) 11 Trial Team. Adherence to Antiretroviral Therapy and Acceptability of Planned Treatment Interruptions in HIV-Infected Children. AIDS and Behavior 2012 May 15

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Hsu DC, Zaunders JJ, Plit M, Leeman C, Ip S, Iampornsin T, Pett SL, Bailey M, Amin J, Ubolyam S, Avihingsanon A, Ananworanich J, Ruxrungtham K, Cooper DA, Kelleher AD. A novel assay detecting recall response to Mycobacterium tuberculosis: Comparison with existing assays. Tuberculosis (Edinb). 2012 Jul;92(4):321-7 Avihingsanon A, Ruxrungtham K, Katner H, Jean Guittari C, Walmsley S. Impact of baseline virologic, immunologic, and demographic characteristics on virologic responses in the gemini study. HIV Clinical Trials 2012 Mar-Apr;13(2):111-7 Aurpibul L, Lumbiganon P, Kolasaraksa P, Hansudewechakul R, Sa-Nguanmoo P, Taeprasert P, Bunupuradah T, Pooworawan Y, Sirisanthana V, Puthanakit T. HIV and Hepatitis B Co-infection among Perinatally HIVinfected Thai Adolescents. The Pediatric Infectious Disease Journal 2012 May 15. Kerr SJ, Avihingsanon A, Putcharoen O, Chetchotisakd P, Layton M, Ubolyam S, Ruxrungtham K, Cooper DA, Phanuphak P, Duncombe C. Assessing adherence in Thai patients taking combination antiretroviral therapy. International Journal of STD & AIDS. 2012 Mar; 23(3):160-5. Bunupuradah B, Ubolyam S, Hansudewechakul R, Kosalaraksa P, Ngampiyaskul C, Kanjanavanit S, Wongsawat J, Luesomboon W, Pinyakorn S, Kerr S, Ananworanich J, Chomtho S, van der Lugt J, Luplertlop N, Ruxrungtham K, Puthanakit T on behalf of the PREDICT study group. Correlation of selenium and zinc levels to antiretroviral treatment outcomes in Thai HIV-infected children without severe HIV symptoms. European Journal of Clinical Nutrition (EJCN) 2012 In press Sitcharungsi R, Ananworanich J, Vilaiyuk S, Apornpong T, Bunupuradah T, Pornvoranunt A, Nouanthong P, Phasomsap C, Khupulsup K, Pancharoen C, Puthanakit T, Shearer WT, Benjaponpitak S; on behalf of the HIV-NAT 108 Study Group. Nephelometry determined serum immunoglobulin isotypes in healthy Thai children aged 2-15 years. Microbiology and Immunology 2012 Feb;56(2):117-122. Rongkavilit C, Naar-King S, Koken JA, Bunupuradah T, Chen X, Saengcharnchai P, Panthong A, Parsons JT. A Feasibility Study of Motivational Interviewing for Health Risk Behaviors Among Thai Youth Living With HIV. J Assoc Nurses AIDS Care. 2012 Jun 8. Rungsiyanont S,Vacharotayangul P,Lam-Ubol A, Ananworanich J,Phanuphak P,Phanuphak N. Perceived dental needs and attitudes toward dental treatments in HIV-infected Thais. AIDS Care. 2012 Mar 20.

Clarke A, Hsu D, Kerr SJ, Ramautarsing R, Ohata pJ, Landolt NK, Avihingsanon A, Maeka-nantawat W, Puthanakit T, Bunupuradah T, Prasitsuebsai W, Ananworanich J, Ruxrungtham K. The 15th Bangkok International Symposium on HIV Medicine, Queen Sirikit National Convention Centre, Bangkok, Thailand, 17-19 January 2012.. Future virology 2012;7(4):341-344 Avihingsanon A, Matthews GV, Lewin SR, Marks P, Sasadeusz J, Cooper DA, Bowden S, SLocarnini, DoreGJ and Ruxrungtham K. Assessment of HBV flare in a randomized clinical trial in HIV/HBV coinfected subjects initiating HBV-active antiretroviral therapy in Thailand. AIDS Research and Therapy 2012 Mar 9;9(1):6 Clarke A, Kerr S, Honeybrook A, Cooper DA, Avihingsanon A, Duncombe C, Phanuphak P, Ruxrungtham K, Ananworanich J and Kaldor J. Adherence and Risk Behavior in Patients with HIV infection receiving Antiretroviral Therapy in Bangkok. The Open Virology Journal 2012;6:23-8 Maek-a-nantawat W, Avihingsanon A, and Ohata PJ. Challenges in treatment and care for viral hepatitis in co-infected individuals with HIV in a resource-limited settings. AIDS Research and Treatment 2012. In Press Landolt NK, Phanuphak N, Pinyakorn S, Lakhonphon S, Khongpetch C, Chaithongwongwatthana S, Ananworanich J. Sexual life, options for contraception and intention for conception in HIV-positive people on successful antiretroviral therapy in Thailand. AIDS Care. 2012 Jan 31 Wilkin A, Pozniak AL, Morales-Ramirez J,Steyn D, Santoscoy M,Grinsztejn B,Ruxrungtham K,Vanveggel S,Termini R,Boven K. Long-term efficacy, safety, and tolerability of rilpivirine (RPV, TMC 278) in HIV type-1 infected antiretroviral-nave patients: week 192 results from a phase IIb randomized trial. AIDS Research and Human Retroviruses 2012; 28(5):437-446. Klinklom A, Puthanakit T, Gorowara M, Phasomsap C, Kerr S, Sriheara C, Ananworanich J, Burger D, Ruxrungtham K and Pancharoen C. Low Dose of Lopinavir/ritonavir Tablet Achieves Adequate Pharmacokinetic Parameters in HIV-Infected Thai Adolescents. Antiviral Therapy 2012;17(2):283-9 Praditpornsilpa K, Avihingsanon A, Chaiwatanarat T, Chaiyahong P, Wongsabut J, Ubolyam S, Chulakadabba A, Avihingsanon Y, Ruxrungtham K, Tunsanga K, Eiam-Ong S, Phanuphak P. Comparisons between validated estimated glomerular filtration rate (GFR) equations and isotopic GFR in HIV patients. AIDS. 2012 Sep 10;26(14):1781-8

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PRESENTATIONS AT CONFERENCES AND MEETINGS

At the time of preparing this annual report, a total of 37 abstracts were accepted, two of which were oral presentations. A total of eight abstracts were accepted at CROI 2012; there were five pediatric abstracts, two on nephrology and one on vitamin D. There were a total of seven abstracts from AIDS 2012 (three were on children, two were on MSM, and one each on fixed dose combination (FDC) TDF/3TC/EFV in adults and website) and six from ASHM 2012. Two abstracts are from the Clinical Research Associates and one from the Clinical Data Associate. This is the first time that the Data Management Team has participated in submitting abstracts to conferences. As for the ICID 2012, a total of six abstracts were submitted of which three were in the pediatric population, and one each on syphilis, hepatitis and prep. As for the Pediatrics workshop, there were 4 abstracts and following that is Glasgow with three abstracts. The ID, ACPID and Liver conference each had one abstract.

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19Th CONFERENCE ON RETROvIRUS AND OPPORTUNITIES INFECTIONS (CROI 2012). SEATTLE, WA USA. MARCh 5-8, 2012.
Bunupuradah T, Chetchotisakd P Jirajariyavej S, Valcour , V, Bowonwattanuwong C, Munsakul W, Klinbuayaem V, Prasithsirikul W, Sophonphan J, Ananworanich J on behalf of HIV STAR study. Neurocognitive Impairments in Patients Using Lopinavir/ritonavir Monotherapy vs Lopinavir/ritonavir-based HAART. [Poster # E-198] Kosalaraksa P, Ananworanich J, Puthanakit T, Pinyakorn S, Chuanjaroen T, Lumbiganon P, Chobkarjing U, Phanuphak P Pancharoen C, Bunupuradah T on behalf , of the HIV-NAT 077 Study Team. Lopinavir/ritonavir Monotherapy in HIV-infected Children; week 144 results. [Poster # S-118] Rongkavilit C, Naar-King S, Klungkang S, Parsons J, Bunupuradah T, Chuenyam T, Koken J, Phanuphak P. Correlations of Sexual Risks, Alcohol Use, and Antiretroviral Adherence in HIV+ Thai Youth. [Poster # S-131]

Ananworanich J, Prasitsuebsai W, Kerr SJ, Phasomsap C, Pankam T, Rodbamrung P, Teeratakulpisarn N, Petdachai W, Sohn, Phanuphak N on behalf of the HIV-NAT 139 Study Group. Prevalence of Cervical and Anal HPV Infection and Intraepithelial Neoplasia Biomarkers in Perinatally and Behaviorally HIV-Infected Compared to HIV-Negative Adolescents. [Poster # S-147] Puthanakit T, Ananworanich J, Vonthanak V, Kosaralaksa P, Hansudewechakul R, Kerr SJ, Kanjanavanit S, Vibol U, Paul R, Ruxrungtham K on behalf of the PREDICT Study Group. Neurodevelopmental Outcome Among HIV-infected Children Older Than 1 Year of Age Randomized to Immediate vs Deferred Antiretroviral Therapy: The PREDICT Study (NCT00234091). [Oral # S-143] (oral presentation) Praditpornsilpa K, Avihingsanon A, Chawatanarat T, Chaiyahong P, Wongsabut J, Ubolyam S, Chulakadabba A, Avihingsanon Y, Eiam-Ong S, Phanuphak P. Validation of Estimated Glomerular Filtration Rate (GFR) Equations Compared With the Isotopic GFR in an HIV Infected Patients [Poster # O-188]

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Avihingsanon A, Praditpornsilpa K, Ramautarsing R, Wongsabut J, Clark A, Mek-Anantawat W, Ubolyam S, Avihingsanon Y, Hiransuthikul N, Ruxrungtham K. Increased risk of Subclinical Kidney Tubular abnormalities in HIV-infected individuals on long term Antiretroviral Therapy: Asian cohort perspective. [Poster # O-195] Ramautarsing R, Avihingsanon A, Praditpornsilpa K, Wongsabut J, Clarke A, Maek-a-nantawat W, Ubolyam S, Khovidhunkit W, Hiransuthikul N, Ruxrungtham K. Prevalence of and Risk factors for Hypovitaminosis D among HIV-infected Adults living in the Tropics. [Poster # O-189]

XIXINTERNATIONAL AIDS CONFERENCE, WAShINGTON DC, USA. JULy 22-27, 2012

Avihingsanon A, Thainsanguankul W, Wongsabut J, Gorowara M, Ramautarsing R, Clarke A, Mek-ananthawat W, Hsu, D, Ruxrungtham K. Virologic success at week 48 among HIV infected Thais using once daily single fixed drug combination tablet of tenofovir, lamivudine and efavirenz (300/300/600) Bunupuradah T, Kosalaraksa P, Vibol U, Hansudewechakul R, Wongsabut J, Kanjanavanit S, Ngampiyaskul C, Wongsawat J, Luesomboon W, Vonthanak S, Ananworanich J, Ruxrungtham K, Puthanakit T on behalf of the PREDICT study group. Impact of antiretroviral therapy on quality of life in HIV-infected children with moderate immune deficiency; week 144 results of the PREDICT randomized control study Ananworanich J, Prasitsuebsai W, Kosalaraksa P, Kanjanavanit S, Ngampiyaskul C, Wongsawat J, Sangkla P, Suwarnlerk T, Sophonphan J, Hansudewechakul R, Wittawatmongkol O, Puthanakit T, Chokephaibulkit K. Outcomes of third-line antiretroviral therapy containing darunavir, etravirine or raltegravir in Thai children with HIV infection Kanjanavanit S, Puthanakit T, Kosalaraksa P, Hansudewechakul R, Ngampiyaskul C, Pinyakorn S, Luesomboon W, Saphonn V, Ananworanich J, Ruxrungtham K and on behalf of the PREDICT studygroup. Lipid profile in children randomized to immediate versus deferred nevirapine-based antiretroviral therapy in the PREDICT study (oral presentation) Yunihastuti E, Phanuphak N, Merati TP, Somia A, Jeo Ws, Indriatmi W, Sukjitpaiboonphol A, Channgam T, Ananworanich J, Phanuphak P on behalf of the MSM VCT Study Group. Sexual practice among HIV-positive and HIV negative/unknown status men who have sex with men in Bangkok, Bali and Jakarta. Phanuphak N, Merati TP, Yunihastuti E, Somia A, Jeo WS, Lisnawati, Sukjitpaiboonphol A, Channgam T, Ananworanich J, Phanuphak P on behalf of the MSM VCT Study Group. High prevalence of abnormal anal cytology among HIV-positive and HIV-negative men who have sex with men in Bangkok, Bali and Jakarta. Nitpolprasert C, Anand T, Ananworanich J, Phanuphak P, Sathianthammawit W, Pakam C, Phanuphak N. Adams Love For Men Who Love Men, an online communication campaign through an edutainment website to promote HIV testing among men who have sex with men (MSM) in Thailand.

15Th INTERNATIONAL CONGRESS ON INFECTIOUS DISEASES AND ThE INTERNATIONAL SOCIETy FOR INFECTIOUS DISEASES, JUNE 13-16, 2012, BANGkOk, ThAILAND
Puthanakit T, Bunupuradah T, Kosalaraksa P, Vibol U, Hansudewechakul R, Ubolyam S, Kanjanavanit S, Ngampiyaskul C, Wongsawat J, Luesomboon W, Saphonn V, Ananworanich J, Ruxrungtham K and on behalf of the PREDICT study group. Low prevalence of HLA B5701 among HIV-infected Thai children in Thailand and Cambodia; implication for abacavir use Ubolyam S, Puthanakit T, Kerr SJ, Kosalaraksa P, Vibol U, Hansudewechakul R, Kanjanavanit S, Ngampiyaskul C, Wongsawat J, Luesomboon W, Vonthanak S, Ananworanich J, Ruxrungtham K on behalf of the PREDICT study group. Plasma HIV viral load and Creactive protein as predictors of HIV disease progression among HIV-infected children. Phongsamart W, Hansudewechakul R, Bunupuradah T, Rakskulkarn P, Keadpudsa S, Teeraananchai S, Kerr SJ, Ananworanich J, Chokephaibulkit K. Long-Term Outcomes of HIV-Infected Children in Thailand: the Thailand Pediatric HIV Observational Database. Poster # 43.023 Maek-a-nantawat W, Jamthong J, Laopraynak N, Moonthong K, Ubolyam S, Avihingsanon A. Syphilis and Risk behaviors among HIV-infected individuals on antiretroviral therapy. Poster # 51.008 Ananworanich J. Implementing PrEP - Are we Ready? Avihingsanon A. Hepatitis B Coinfection: Implication for management

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4Th INTERNATIONAL WORkShOP ON hIv PEDIATRICS, JULy 20-21, 2012, WAShINGTON DC, USA
Prasitsuebsai W, Pang J, Hansudewechakul R, Razali K, Yusoff N, Moy FS, Teeraananchai S, Kerr SJ, Ananworanich J and Sohn AH. Risk Behaviors and Treatment Adherence among HIV-infected Adolescents in the TREAT Asia Pediatric HIV Observational Database Panthong A, Kosalaraksa P, Wongsabut J, Puthanakit T, Lumbiganon P, Chuanjaroen T, Sopharak C, Prasitsuebsai W, Ananworanich J, Bunupuradah T on behalf of the HIV-NAT 077 Study Team. Quality of life in HIV-infected children using treatment simplification to lopinavir/ritonavir monotherapy Bunupuradah T, Imahashi M, Iampornsin T, Matsuoka, Iwatani, Puthanakit T, Ananworanich J, Sophonphan J, Mahanontharit A, Naoe T, Phanuphak P, Sugiura W on behalf of the PREDICT Study Team. Association of APOBEC3G and disease progression in Thai and Cambodian HIV-infected children with moderate immune deficiency. Jantarapakde J, Pancharoen C, Teeratakulpisarn S, Mathajittiphan P, Kriengsinyot R, Channgam T, Pengnonyang S, Jupimai T, Plodgratok P, Lakhonphon S, Luesomboon W, Jadwattanakul T, Avihingsanon A, Phanuphak N, Ananworanich J, Ungaro P, Phanuphak P. Willingness of Thai HIV-infected parents to disclose their HIV status to their children.

Bencharat T, Chavalun R, Mark B, Peeraporn K, Chalandakorn R, Alli H, Wipada C, Anchalee A, Kiat R, Torsak Bon behalf of LASA study team. Acceptability of web-based electronic data capture in a multicentre randomized trial in Thailand. [Poster #265] Kerr, SJ, Rattanamahattana, M, Chetchotisakd, P, Cabarrubias, H, Putcharoen, O, Ananworanich, J, Imrie, J, Cooper, DA, Phanuphak, P, Avihingsanon, A. Supportive relationships with the clinic team empowers Thai people living with HIV to maintain excellent adherence [poster # 276] Kerr, SJ, Gorowara, M, Phonphitak, S, Ananworanich, J, Burger, D, Ruxrungtham, K, Avihingsanon, A. Predictors of daily tenofovir exposure in Thai subjects taking combination antiretroviral therapy. [Poster # 368]. Chalandakorn R, Ploenchan C, Supunnee J, Apicha M, Jiratchaya S, Victor G. V, Chureeratana B, Warangkana M, Virat K, Wisit P, Peeraporn K, Bernard H, Kiat R, Jintanat A, Torsak B on behalf of HIV STAR study group. Neurocognitive impairment and cerebrospinal fluid HIV-RNA in Thai HIV-infected adults failing non-nucleoside reverse transcriptase inhibitor based antire-troviral therapy. [Poster #755]

A JOINT MEETING OF IDSA, ShEA, hIvMA, AND PIDS. SAN DIEGO, CA, USA. 17-21 OCTOBER 2012.
Ngampiyaskul C, Vibol U, Sophonphan J, Hansudewechakul R, Vonthanak S, Kosalaraksa P, Kanjanavanit,S, Wongsawat J, Luesomboon W, Suwanlerk T, Fox L, Ananworanich J, Ruxrungtham K, Puthanakit T on behalf of the PREDICT study group. Growth outcomes in children randomized to early versus deferred antiretroviral therapy in the PREDICT study. [Poster # 36283].

ThE LIvER MEETING, ANNUAL MEETING OF ThEAASLD- AMERICAN ASSOCIATION FOR ThE STUDy OF LIvER DISEASES, BOSTON, MA, USA. 11-13 SEPT 2012
Ali RJ, Bowden S, Avihingsanon A, Lewin SR, Ruxrungtham K, Locarnini S, Sasadeusz J, Dore GJ and Matthews GV. Changes in Quantitative HBsAg and HBeAg Predict HBV Treatment Response in HIV/HBV Coinfected Individuals on Tenofovir based HAART in Thailand.

INTERNATIONAL CONGRESS ON DRUG ThERAPy IN hIv. GLASGOW, GLASGOW, Uk. 11-15 NOvEMBER 2012
Avihingsanon A, Mek-A-nantawat W, Apornpong T, Akkarathamrongsin S, Ubolyam S, Chomhong P, Tangkitvanich P. Distribution of HCV genotype and Single Nucleotide Polymorphisms (SNPs) of IL-28B gene in HIV/HCV coinfected Thai Populations. [Poster # P132] Avihingsanon A, Praditpornsilpa K, Avihingsanon Y, Wongsabut J, Klongpetch C, Ubolyam S, Ruxrungtham K. Association of Fibroblast growth factor 23 and hypophosphatemia in well suppressed HIV infected patients receiving antiretroviral therapy. [Poster # P046]

AUSTRALIAN hIv/AIDS CONFERENCE 2012 24Th ANNUAL CONFERENCE OF ThE AUSTRALIAN SOCIETy FOR hIv MEDICINE, MELBOURNE, AUSTRALIA. 17-19 OCTOBER 2012
Pussadee K, Clarke A, Taylor J, Kerr S, Avingsanon A , Keawon P, Emery S, Phanuphak P, Puls R. Experience in setting up a Thai Coordinating Centre. [Poster # 130]

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Maekanantawat W, Avihingsanon A, Thainsanguankul W, Wongsabut J, Gorowara M, Ramautarsing R, Clarke A, Hsu D, Ruxrungtham K. Safety and efficacy of once daily single generic fixed drug combination tablet of tenofovir, lamivudine and efavirenz among HIV infected Thais. [Poster # P312] Avihingsanon A, Maek-a-nantawat W, Ananworanich J, Sithinamsuwan P, Suksawak S, Saysombut N, Charoenporn W, Valcour V. Impaired neurocognitive function among HIV-infected Thais on stable antiretroviral therapy for more than 7 years. [poster #P220] Maek-a-nantawat W, Phanuphak N, Teeratakulpisarn N, Kanteeranon T, Chaiya O, Mansawat T, Ananworanich J, Phanuphak P. Interest in the Test and Treat strategy for HIV prevention among men who have sex with men living in Bangkok. [poster # P231]

6Th ASIANCONGRESSOF PEDIATRIC INFECTIOUS DISEASES (ACPID 2012). BMICh, COLOMBO, SRI LANkA. 28 NOv 1 DEC 2012
Bunupuradah T, Techasaensiri, Keadpudsa S, Thammajaruk N, Srimuan A, Sahakijpicharn T, Prasitsuebsai W, Ananworanich J, Puthanakit T. on behalf of the HIVNAT 146 study team. Pharmacokinetics of atazanavir/ ritonavir among Thai HIV-infected children concomitantly taking tenofovir disoproxil fumarate. Oral presentation A-477-0009-00205.

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HIV-NAT RESEARCH LABORATORY

The HIV-NAT Research Laboratory is located on the 7th floor of the Research Building at Chulalongkorn University Hospital, which is 150 feet from the HIV-NAT main building. HIV-NAT laboratory serves as the central laboratory for the PREDICT study. In addition, HIV-NAT is responsible for training, quality assurance, data collection and analysis for all sites.

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The HIV-NAT laboratory facility comprises approximately 2500 square feet of space. The laboratory has the capacity to perform diagnostic immunoassays, cell phenotyping by flow cytometry, HIVRNA, hepatitis and syphilis serology and molecular testing, haematology, chemistry and HIV pharmacokinetics. The laboratory provides serum HIV and diagnostic serology testing for HIV, HBV and HCV, and molecular quantitation of HIV by Cobas Ampliprep Taqman (Roche),and Abbott Molecular, CMV as well as MTB/ RIF assay by TB Xpert. The laboratory also provides 2-, 3- and 4-color flow cytometry for T-cell phenotype analysis for adult and paediatric studies. HIV-NAT Research Laboratory has been performing pharmacokinetics and therapeutic drug monitoring studies for several years. HIV-NAT PK laboratory has provided commercial services for therapeutic drug monitoring for tenofovir, efavirenz, nevirapine, raltegravir and all protease inhibitors. Our research studies focus on issues relevant to the Asian setting such as dose reduction of several antiretrovirals and quality assessment of many generic products. Our pharmacokinetic laboratory participates in the Association for Quality Assessment in Therapeutic Drug Monitoring and Clinical Toxicology (KKGT) program The laboratory participates in the college of American

Pathologists (CAP) for flow cytometry. Viral quantitation is certified by Virology Quality Assessment Program (VQA) from Rush Presbyterian-St. Lukes Medical Center Chicago, Illinois, and also from CAP. All laboratory assays has external quality assurance program with CAP or CAP approved provider. HIV-NAT laboratory has already received CAP accreditation in April 2009 (LAP Number :7197506, AU-ID : 1475967). A PC network has been established throughout the laboratory. The Cobas IT 5000 Solution laboratory information system was implemented to HIV-NAT laboratory, the functions implemented in HIV-NAT laboratory considerably increase efficiency in all areas of laboratory workflows from quality control and order processing all the way to the technical/medical validation of the patients samples. There is computer system for each tech-nicians connected to the network with direct access to printing and the Internet. HIV-NAT research laboratory serves as the central specimen repository for many studies. The laboratory is in compliance with all applicable safety and administrative requirements for GCLP and is audited annually by staff from NCHECR, St Vincents Hospital, Sydney, Australia and DAIDS officer, USA.The specimen storages are kept in -70 freezer. HIV-NAT laboratory handles specimen storage for both short-term and long-term storage, therefore the adequate of equipment, facilities and management of specimen repository at HIV-NAT pose a challenge.

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HIV-NAT research laboratory has been responsible for shipping samples from all sites. HIV-NAT laboratory staff members have been trained on shipment of biological samples and given a manual to follow. This document includes information on how to properly classify, package, mark and label shipment. Diagnostics Specimens, infectious substances and other biological materials are regulated by International Air Transport Association (IATA). Infectious substances and materials categorized as Dangerous Goods are always transported according to the appropriate regulations. HIV-NAT has several staff members that are IATA-certified. They provide training to other staff every 2 years. The HIV-NAT laboratory has been involved with processing, storing and shipping of research specimens, including peripheral blood mononuclear cells (PBMCs), for the NIH sponsored studies for the past 10 years. HIV-NAT Laboratory acts as a local central lab for Peripheral Blood Mononuclear Cells (PBMC) procedure for the management of MERCK clinical research study as well as GSK clinical research study in the future.

Staff:
Laboratory Director: Prof. Kiat Ruxrungtham Laboratory Manager: Sasiwimol Ubolyam Laboratory Quality Manager: Apicha Mahanontharit Total number of staff: 18, consist of 7 Laboratory Medical Technologist, 2 Scientist, 2 Pharmacologist, 2 Senior Laboratory assistant, 2 laboratory assistant and 1 lab Secretary and 1 part time Medical Technologist

Auditor/Consultant:
The HIV-NAT research laboratory has been identified as a model, operating in accordance with the principles of Good Laboratory Practice required by pharmaceutical industry. Much of the work of the laboratory is directed towards the provision of routine clinical support for clinical trials and specimen preparation. The laboratory functions as a central laboratory for multi-centre studies, including sites throughout Thailand and a large number of national and international pharmaceutical clinical trials. In addition, in 2012, HIV-NAT Research Laboratory received the Thailand Biorisk Management Champions Award for its excellent management of Biosafety level 2 in clinical laboratory. This award was bestowed to laboratories which serve as a model in Biorisk management.

Phillip Cunningham, senior operations manager, St.Vincents hospital, Australia Mike Ussery, Division of AIDS, NIH, USA Neal Wetherall, Division of AIDS, NIH, USA

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COLLEGE OF AMERICAN PATHOLOGISTS

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THE VACCINE AND CELLULAR IMMUNOLOGY LABORATORY (VCI Lab)

Chulalongkorn University Medical Research Centre (Chula-MRC) and Chula Vaccine Research Center (Chula-VRC)

The VCT Team (Left to Right) Arun Buaklin (Research Assistant), Pattarawat Thantiworasit (Research Assistant), Pinya Pulsawat (Research Assistant), Montalee Theeraapisakkun (Research Assistant), Sunee Sirivichayakul (Ph.D, Medical Technologist and Head of VCI Laboratory), Supranee Buranapraditkun (Medical Technologist), Patrawadee Pitakpolrat (Research Assistant), Suwanna Mekprasan (Research Assistant), Mongkol Pongsuchart (M.Sc student) Missing:
Chutitorn Ketloy, Ph.D., Instructor Akachai Prompet (Ph.D. student) Kaj Chokechai-u-saha (Ph.D. student)

RESEARCH PROjECTS
1. Construction of Asian Mosaic Subtype AE/B envelope HIV DNA Vaccine and immunogenicity testing in Balb/C mice
The mosaic subtype AE/B envelope HIV DNA has been designed from 113 CRF01_AE and 59 clade B as 3 mosaic clones, i.e., mosaic 1, mosaic 2 and mosaic 3, respectively. The subtype AE/B envelope HIV DNA constructs were successfully cloned into pCMVkan and have been proven to be well expressed by in vitro protein transfection. The in vivo immunogenicity testing in Balb/C mice showed that the constructs were immunogenic and could induce both cell-mediated (by ELISpot assay) and humoral (anti-gp120/160 and anti-gp41) immune responses as well as a low neutralizing antibody titer.

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2. Dengue prime-boost vaccination strategy combining the electroporation-delivered tetravalent DNA vaccines with live attenuated vaccines in mice and non-human primate
In order to prevent dengue infection, various vaccine approaches have been developed and no approved vaccine is currently available for clinical use. Although the most progressive vaccine development is live attenuated virus-based vaccine (LAV), it can potentially promote collateral side effects due to a combination of infectious viruses. A DNA-based vaccine encoding specific dengue sequences is an alternative strategy as it is noninfectious, however their efficacy needs improving. In this project, several methods are proposed to enhance the DNA-based vaccine immunogenicity that have been developed in Phase I study (sup-ported by BIOTEC) including: using in vivo electroporation for DNA delivery and using prime-boost vaccination strategy by combining DNA vaccine with LAV. Recently, there are two studies demonstrated that prime-boost vaccinations of DNA vaccine with LAV or infective viruses are able to induce higher antibody levels. However, no study reported the effect of LAVs prime and DNA vaccine boost. Here, we asked whether in vivo electroporation of prime-boost vaccination, combining the two types of candidates, tetravalent live attenuated vaccine (TLAV) with tetravalent DNA vaccine (TDNA) would increase the immunogenicity of our dengue DNA vaccine. We plan to conduct this project into two phases. The first phase (first year) will be used to proof the concept of prime-boost vaccination strategy in mice. If the high titers neutralizing antibody is observed, the second phase (second and third year) will be further evaluated in nonhuman primate (rhesus macaque). Status: Currently, the dose titration study of LAV are evaluating in mice. Collaborators/sites: Department of Microbiology, Faculty of Medicine, Chiangmai University Funding: The National Center for Genetic Engineering and Biotechnology (BIOTEC), Thailand

Publications: 1. Nguyen HL, Ruxrungtham K, Delaugerre C. Genetic barrier to the development of resistance to integrase inhibitors in HIV-1 subtypes CRF01_AE and B. Intervirology 2012; 55 : 287-295. 2. Le Nguyen H, Pitakpolrat P, Sirivichayakul S, Delaugerre C, Ruxrungtham K. Minority HIV-1 resistant variants in recent infection and in patients who failed first-line antiretroviral therapy with no detectable resistance-associatd mutations in Thailand. J Med Virol 2012; 84 : 713-720. 3. Rutvisuttinunt W, Sirivichayakul S, Oota S, Assawadarachai V, Poltavee K, Savadsuk H, Pattanachaiwit S, Chaemchuen S, Arroyo MA, Paris RM, Michael NL, Kim JH, Ruxrungtham K, Souza MD, Phanuphak P, Tovanabutra S. Two unique recombinant forms identified in incident HIV type 1 infections in Thai blood donors. AIDS Res Hum Retroviruses 2012; [Epub ahed of print].

4. Wangrattanasopon P, Ruxrungtham K, Chantaphakul H, Buranapraditkun S, Klaewsongkram J. Alkali-treated penicillin G solution is a better option than penicillin G as an alternative source of minor determinants for penicillin skin test. Allergy Asthma Proc 2012; 33 : 152-159. 5. Tanvarasethee B, Buranapraditkun S, Klaewsongkram J. The potential of using enzymelinked immunospot to diagnose Cephalosporininduced maculopapular exanthems. Acta Derm Venereol 2012; [Epub ahed of print].

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Education and dEVELoPmEnt Program

Education and training Program 2012 1. For Staff
1.1 Advanced GCP and HSP training course for 84 attendees on 3-4 May 2012 1.2 HIV Medicine for staff training: The training was held on 5 July 2012. It was attended by 71 participants, including staff from following units and organizations under the Thai Red Cross Society: National Blood Centre Thai Red Cross Youth Thai Red Cross Eye Bank Relief and Public Health Bureau First Aid and Home Health Care Training Center Red Cross College of Nursing Administration Office Up to 5 nurses from Army Nursing College also attended the HIV Medicine for staff training. 1.3 Special meeting; Life empowering monthly meeting by Landmark graduate staff: The big life empowering event on 23 March 2012 was attended by 145 staff. Monthly meetings were attended by 45-50 staff. 1.4 Special lecture; 6 clinical trial short courses training by the MD team were held from 22 March 10 May 2012. Up to 45 staff attended the courses

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2. For Physicians and Medical Personnel in Thailand and South East Asia
HIV-NAT Symposium Series: HIV-NAT provides in-depth training as a series of workshops for health care professionals: physicians, nurses, pharmacists, scientists and others health care providers who are interested in the care of HIV infected patients. Workshop participants will be able to diagnose and give appropriate and proper care to HIV-infected patients.

In 2012, HIV-NAT organized a workshop on the topic of liver disease. The HIV and Hepatic Diseases workshop was held on February 27-28, 2012 at Chulalongkorn Hospital and conducted entirely in Thai. Up to 100 participants from 40 hospitals in Thailand attended.
HIV-NAT/Gilead Medical Education Program in Asia took place from October 2011 to May 2012. The objectives are to improve the HIV care in Asia by educating and mentor key healthcare providers and key PLHIV volunteers in Asian countries with less experience in HIV care and create a network of HIV experts in the Region that can further cross-consult, share experience and collaborate in advocacy activities and research. Participants were HIV physicians from 9 countries: Myanmar, Laos, Vietnam, Cambodia, Indonesia, Philippines, Pakistan, Sri Lanka and Nepal. The first course, Pediatric HIV and Co-infection which was held on 19-21 October 2011 was a success. The topics and numbers of participants for the 4 following courses are as follows:

Course 2: Main course; Update on HIV Medicine Date: 9-20 January 2012 Course 3: Treatment Failure & HIV Drug Resistance Date: 13-15 February 2012 Course 4: HIV and Hepatic Disease Date: 26-28 March 2012 Course 5: Update on PMTCT Date: 14-16 May 2012

66 participants 39 participants 40 participants 32 participants

trainings
The Thai Red Cross College of Nursing Training Course: HIV/AIDS, TB and Care September 3, 2012 Survival analysis in Pharmacoepidemiology. Graduate programme in Social and Administrative Pharmacy, Department of Pharmaceutical Sciences, Chulalongkorn University, Bangkok. Thailand. August-September 2012 1. Neurocognitive outcomes from the PREDICT study at Think Tank on Neurocogitive Research Priorities for children and adolescents with HIV organized by TREAT ASIA on 20 February 2012 2. Update management of pediatric HIV organized by Bureau of AIDS, TB and STIs Ministry of Public Health 8 March 2012, Bangkok, Thailand 3. HBV prevention and care in HIV-infected children: results from recent research. at a Research Agenda for Diagnosis, Prevention and Treatment of HIV, HBV, and HPV Infections in Southeast Asia, organized by PHPT 14-15 March, Chiang Mai, Thailand 4. PMTCT in Thailand; Role of LPV/r for HIV mother to child transmission prevention at the HIV/AIDS Expert meeting organized by the Indonesia Association of Physicians in AIDS Care (PDPAI), on 12 May 2012, Jakarta, Indonesia 5. How to manage treatment failure without genotyping Workshop on diagnosis and management of pediatric antiretroviral therapy failure organized by TREAT ASIA on 3 July 2012, Phnom Penh, Cambodia

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studEnt suPErVision HiV-nat 2012

Supervisor Anchalee Avihingsanon Thanaporn Wattanakul Masters student at Chulalongkorn University Population Pharmacokinetics of Nevirapine in HIV-infected patients Anchalee Avihingsanon and Jintanat Ananworanich Thep Chalermchai, SEARCH Physician PhD candidate at Chulalongkorn University Risk Factors for Chronic Hepatitis in HIV-Infected, Thai individuals without Hepatitis B or C Virus Co-Infection Jintanat Ananworanich and Anchalee Avihingsanon Akapirat Siriwat, AFRIMS Laboratory Technologist PhD candidate at Mahidol University Establishment of Anti-HIV-1 Neutralizing Human Monoclonal Antibodies (NhMAbs) from Thai HIV-1-infected Individuals Stephen Kerr, Jintanat Ananworanich (Primary supervisors Anthony Kelleher, David Cooper) Denise Hsu, HIV-NAT Physician PhD candidate at the University of New South Wales Antigen specific CD4 immune responses in chronic HIV infection Jintanat Ananworanich (Primary supervisors Anthony Kelleher, David Cooper) Sasiwimol Ubolyam, HIV-NAT Laboratory Manager PhD candidate at the University of New South Wales Specific immune response pattern in persons with active tuberculosis before and after receiving anti-tuberculous therapy Thanyawee Puthanakit Neda Esmailzadeh Medical student at University of Copenhagen, Denmark Prevalence of insulin resistance among HIV-infected children receiving lopinavir/ritonavir

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Supervisor

Thanyawee Puthanakit Piyada Udomchaisakul Pediatric resident at Faculty of Medicine, Chulalongkorn University Association of SCLO1B1 polymorphism and plasma concentration of lopinavir in HIV-infected children Thanyawee Puthanakit, Torsak Bunupuradah Passorn Bunyahotara Pediatric Infectious Disease Fellow at Faculty of Medicine, Chulalongkorn University Pharmacokinetics of Abacavir once daily vs. twice daily and Lamivudine once daily vs. twice daily in HIV-infected Thai Children Praphan Phanuphak, Tomoki Naoe, Wataru Sugiura Torsak Bunupuradah, HIV-NAT Physician PhD candidate at Nagoya University Graduate School of Medicine Association of APOBEC3G genotypes and CD4 decline in Thai and Cambodian HIV-infected children with moderate immune deficiency, 2011 - 2015 Joep Lange, Praphan Phanuphak, David Burger, Jintanat Ananworanich, Ferdinand Wit, Janneke van de Wijgert Reshmie Ramautarsing, HIV-NAT Physician PhD candidate at the University of Amsterdam Optimizing long term care for HIV-infected patients in Thailand, 2009 2013 Joep Lange, Joel Palefsky and Jintanat Ananworanich Nittaya Phanuphak, SEARCH and Thai Red Cross AIDS Research Centre Physician PhD candidate at the University of Amsterdam Promoting early detection of HIV and anal dysplasia in Thai men who have sex with men, 2009 2013 Joep Lange and Jintanat Ananworanich Nadia Kancheva Landolt, HIV-NAT Physician PhD candidate at the University of Amsterdam Optimization of reproductive health care for HIV-positive women, 2009-2013 Jintanat Ananworanich Megan Rux, High school student, Chicago Learning about HIV in children Jintanat Ananworanich and Thanyawee Puthanakit Lindsay Anne Stevens, MD Pediatric resident at Stanford University Pediatric HIV and infectious diseases clinics observation Jintanat Ananworanich and Thanyawee Puthanakit Midori J.Seppa, MD Pediatric resident Stanford University Pediatric HIV and infectious diseases clinics observation Jintanat Ananworanich, Victor Valcour and Serena Spudich Idil Kore, Medical Student Yale School of Medicine Neuropsychological profile in Thai patients with acute HIV infection Jintanat Ananworanich James Fletcher Annirudh Balachandran, Medical student Tufts University School of Medicine HIV clinic observation Jintanat Ananworanich, Anchalee Avihingsanon Reshmie Ramautarsing Tara Mackay, Medical Student University of Amsterdam HIV clinic observation HPV in HIV-infected adolescents Jintanat Ananworanich Reshmie Ramautarsing Bas Bindels University of Amsterdam Literature research

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15tH bangkok intErnationaL sYmPosium on HiV mEdicinE

18 - 20 JanuarY 2012
at the Queen sirikit national convention centre, bangkok, Thailand

The Bangkok International Symposium on HIV Medicine is the largest HIV meeting in Asia attended by more than 700 participants each year from Asia Pacic, Europe and the Americas. Its speakers are well known experts in various elds from Thailand, Asia, Australia, Europe and the USA. This is HIV-NATs 15-year, strong commitment to continuously provide health care professionals a comprehensive review and up-to-date information on HIV medicine management for the Asia-Pacic region at the Queen Sirikit National Convention Centre every January for a total of three days. Several plenary sessions are focused on selected hot topics and conducted in the morning whereas the interactive workshops with electronic e-voting machines are carried out in the afternoon. The most engrossing session is the great debate in which provocative issues concerning HIV management are articulated to elicit strong reactions and opinions from the participants.
A year later, the follow-up results of the Berlin Patient was reported in the WorkshoponHIVand Hepatitis Virus DrugResistanceand Curative Strategies held in Sitges,Spain and this further propelled the HIV eradication field in to the spotlight. As for the HIV acute, this is relatively a new field of study as it is very difficult to find subjects recently infected. Subjects with negative antibody tests are enrolled in to the study and then followed over time until they become infected. Aside from the known data on CD4 depletion and elevation of viral load, it was discovered in 2004 that the gut CD4 memory T cells were also important and were significantly destroyed within the first few days of infection. Primary HIV infected subjects can also exhibit the same clinical manifestations as those with AIDS such as oral candida and maculopapular rash on the hand and soles of the feet, mimicking syphilis. Even nonspecific symptoms can occur making it difficult to sometimes diagnose the subjects. Treatment recommendations vary according to the different treatment guidelines available worldwide as many groups are unsure as what to do with this group of subjects. In the SPARTAC randomized clinical trial, it was shown that there were no differences in the CD4 levels between the short course 12 weeks versus the no treatment group. The reasons provided for treating PHI subjects are: 1. Preserve HIV specific CD4 T cells, 2. Prevent HIV transmission to other people since the viral load at this time will be extremely high, and 3. Able to reduce latent reservoir so functional cure or sterilizing cure is possible. One of the studies mentioned is the RV254 by Dr. Jintanat Ananworanich and the US Military HIV Research Program. This study is examining the use of megaHAARTs (5 drugs) vs HAARTs (3 drugs) on latent reservoir in

The topics ranged from prevention, vaccines, acute HIV infection, antiretroviral therapy (ART), treatment complications in adults and the pediatric population, resistance, aging, pharmacokinetics/pharmacogenomics, HIV eradication, hepatitis and tuberculosis. This is the first time that HIV eradication and HIV acute are presented at the Symposium. For the past few years, after several disappointing HIV vaccine results, the idea for HIV eradication was abandoned until the ThaiPhase IIIHIV VaccineClinical Trial RV144 reported at a press conference of having a vaccine efficacy of 26.4%. Updated information from the RV 144 study was also presented at Fridays plenary entitled, HIV vaccine: New data from RV144 and the way forward. In additional, around the same time, the results from the CAPRISA 004 Phase IIb microbicide trial of 1% tenofovir (TDF) gel announced at the XVIIIth International AIDS Conference in Vienna, Italy that it was able to reduce HIV incidence by 39% among women from the TDF group. Both announcements energetically renewed the efforts in the field of HIV eradication.

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various compartments. By treating PHI subjects, misdiagnosis, numerous medical visits, rapid progression and HIV transmission to others can be avoided. Other topics commonly requested by participants on a continuous basis are hepatitis and tuberculosis as this area is epidemic for both diseases. Aside from those topics, lectures on different ART strategies such as when to start and what to start, what kind of care is needed for those who do not need ART, how to optimize treatment, how to deal with long-term complications and resistance as well as new ARVs in the pipeline were presented. Innovative strategies in sustaining HIV health care programs amidst economic troubles worldwide were provided which Thailand is starting to use. In August 2012, the Thai government announced that the excise taxes for alcohol and cigarettes would be increased. For example, white spirits was increased up to 150 baht per liter if the alcohol content was 100% which was an increase of only 30 baht. For blended spirits, the tax was increased to 350 baht per liter if the alcohol content was 100%. As for cigarettes, the taxes were increased by 2%, from 85% up to 87%. Along the same lines as last years debate topic, the question addressed whether PrEP should be used for HIV prevention or not among MSMs. Initially, before the debate, 42.2% were against offering PrEP to MSM as part of the standard HIV prevention program whereas 34.4% were for and 22.2% were undecided.

After the advantages and disadvantages were vigorously presented from both sides, there was a 10% increase for the no team unlike the yes team which was half of that. More than half of the audience were swayed by the notion of offering PrEP to their patients however they do not think that this should be part of the standard care. As a result of this, the no team won the argument effortlessly. This is just a brief glimpse into the Symposium. Since there are so much going on, the best way to get all of the information is to attend the symposium. Not all sessions can be briefed in the Conference Scene. For more information, you can go to the Conference Scene published in Future Virology, April 2012, Vol. 7, No. 4, Pages 341-344 (http://www.futuremedicine. com/toc/fvl/7/4) or download the slides and/or watch the webcasts for free at www.hivnat.org. Some slides are not provided as per speakers request.

e next Symposium has topics that are just as riveting as this one! It will be held on January 16-18, 2013 at the Queen Sirikit Convention Centre in Bangkok, ailand.

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PartnErsHiP
The Ministry of Public Health, Thailand provides:

policy direction through membership of the HIV-NAT international advisory board approval for the importation of study materials assistance with the provision of study medications

tHE Foundation For aids rEsEarcH (amFar) EstabLisHmEnt oF tHE amFar oFFicE in bangkok, tHaiLand
The amfAR office in Thailand was established with the successful completion of the application to the Ministry of Labor in April of 2006. As reported in the application, this office is intended to support the regional efforts of the TREAT Asia (Therapeutics Research, Education and AIDS Training in Asia) program (http://www.amfar.org/ treatasia). The program was originally launched in July 2001 and is intended to provide support for the safe and effective delivery of HIV treatments in Asia. The program is currently supporting projects in 14 countries and economies in the Asia-Pacific including Australia, Cambodia, China, Hong Kong, India, Indonesia, Japan, Malaysia, the Philippines, Singapore, South Korea, Taiwan, Thailand and Viet Nam. The projects focus on four primary objectives: research, education and training, public policy,and strengthening civil society through treatment education. The program currently employs 18 staff members.

TAHOD: The TREAT Asia HIV Observational Database (TAHOD) is a collaborative observational cohort study,

which involves 21 participating sites in the Asia-Pacific, including HIV-NAT/Thai Red Cross (Bangkok), Ramathibodi Hospital (Bangkok) and Chiang Mai University - Research Institute for Health Science (Chiang Mai). The primary objectives of TAHODare to: 1. 2. 3. 4. 5. Develop capacity in HIV clinical data collection in countries of the Asia-Pacific region; Assist in evaluation of new HIV treatments for the Asia-Pacific region; Monitor antiretroviral and prophylactic treatment; Monitor toxicity to antiretroviral therapy; and Examine HIV natural history, including the relationship between access to antiretroviral therapy and disease progression.

The project was established in 2003 and has enrolled ~8,000 patients. Sub-studies within the adult program have allowed for more in-depth research on specific topics (e.g., renal function, tuberculosis). The program is supported in part by a grant from the US National Institutes of Health.

TAHOD Publications are as follows:

1. Zhou J, et al. J Acquir Immune Defic Syndr. December 2006; 43(4): 501-503. 2. Zhou J, at el. Antiviral Therapy 2007;12(Suppl.2):L45 3. Zhou J, et al. Clin Infect Dis. January 2007;44(1): 147-149 4. Zhou J, et al. HIV Medicine. January 2007;1(8): 816. 5. Zhou J, et al. Int J STD AIDS. 2007 Jul;18(7): 446-52. 6. Huffam SE, et al. HIV Med. August 2007, 8(7): 465-471. 7. Srasuebkul P, et al. AIDS Research and Therapy. September 2007, 4:18. 8. Zhou J, et al. J Gastroenterol Hepatol. September 2007, 22(9): 1510- 1518. 9. Zhou J, et al. BMC Infect Dis. 2009 Apr 21;9:46. 10. Srasuebkul P, et al. Clin Infect Dis. 2009 Apr 1;48 (7):940-50. 11. Pujari S,et al. J Antivir Antiretrovir. 2009 Nov 1;1(1):28-35 12. Zhou J, et al. HIV Medicine 2010 Jan.11(1):31-39 13. Oyomopito R, et al. HIV Med. 2010 Sep;11(8):519-29. 14. Achhra AC, et al. AIDS Clin Res. 2010 Oct 8;1(1):1-4 15. Zhou J, et al. BMC Infect Dis. 2010 Dec 23;10:361 16. Petoumenos K, et al. J Int AIDS Soc. 2010 Dec 10;13:51 17. Han SH, et al. Endocr J. 2011 Apr 27. 18. Zhou J, Tanuma J, Chaiwarith R, Lee CK, Law MG, Kumarasamy N, Phanuphak P, Chen YM, Kiertiburanakul S, Zhang F Vonthanak S, Ditangco R, , Pujari S, Choi JY, Parwati Merati T, Yunihastuti E, Li PC, Kamarulzaman A, Nguyen VK, Thuy Pham TT, Lim PL. Loss to Followup in HIV-Infected Patients from Asia-Pacific Region: Results from TAHOD. AIDS Research and Treatment 2012; 2012: 375217. 19. Lim PL, Zhou J, Ditangco RA, Law MG, Sirisanthana T, Kumarasamy N, Chen YMA, Phanuphak P, Lee CKC, Saphonn V, Oka S, Zhang F Choi JY, Pujari S, , Kamarulzaman A, Li PCK, Merati TP, Yunihastuti E, Messerschmidt L, Sungkanuparph S and TREAT Asia HIV Observational Database (TAHOD). Failure to prescribe pneumocystis prophylaxis is associated with increased mortality, even in the cART era: results from the Treat Asia HIV Observational Database. Journal of the International AIDS Society 2012, 15:1 doi:10.1186/1758-2652-15-1

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TAHOD presentations are as follows:

1. AIDS defining illness diagnosed within 90 days after starting HAART among TAHOD patients. Presented at the 3th IAS Conference on HIV Pathogenesis and Treatment, Rio de Janeiro, Brazil, 24-27 July 2005 2. Experience with the use of a first-line regimen of stavudine, lamivudine and nevirapine among TAHOD patients. Presented at the 17th ASHM Conference, Hobart, Australia, 24 27 August 2005 3. Difference between Asian and Caucasian HIV-infected patients in absolute CD4 count and CD4 percentage. Presented at the 10th International Workshop on HIV Observational Databases, Madrid, Spain, March 23-26, 2006and XVI International AIDS Conference. Toronto, Canada 13-18 August 2006 4. Risk of active tuberculosis (TB) and prognostic significance of tuberculosis among TAHOD patients. Presented at the 10th International Workshop on HIV Observational Databases, Madrid, Spain, March 23-26, 2006and XVI International AIDS Conference. Toronto, Canada 13-18 August 2006 5. Parametric models of immunological failure in HIVinfected Thais receiving antiretrovirals at HIV-NAT and validation using the TAHOD. Presented at the 18th Annual Conference of the Australasian Society for HIV Medicine. Melbourne, Australia, 11 to 14 October 2006 6. Experience Using AZT and d4T in TAHOD Patients: Treatment Duration and AZT Related Anaemia. Presented at the 14th CROI, Los Angeles, USA, Feb 25-28, 2007 7. Data Collection for Antiretroviral Treatment Related Adverse Events (AEs) in The TREAT Asia Observational 8. Database. Presented at the 11th International workshop on HIV Observational Databases, Monte Carlo, 22-25 March 2007 9. Antiretroviral Treatment Related Adverse Events (AEs) in The TREAT Asia HIV Observational Database. Presented at the 9th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV, Sydney, 1921st July 2007 10. Measures of country-specific resourcing predict virologic suppression, immunologic response and disease progression in the TREAT. Presented by the 12th International Workshop on HIV Observational Databases, Malaga, Spain, 28 March 2008 and 20th Annual Australasian Society for HIV Medicine (ASHM) Conference, Perth, 17-20 September 2008 11. Deferred modification of antiretroviral regimen following treatment failure in Asia: Results from The TREAT Asia HIV Observational Database (TAHOD). [Poster#: TUPE0116] Presented at the 17th International AIDS Conference, Mexico City, Mexico, 3-8 August 2008 12. HIV Disease Progression In HIV-1 Patients Initiating Combination Antiretroviral Therapy With Advanced Disease In The Asia-Pacific Region: Results From The TREAT Asia HIV Observational Database (TAHOD). Presented at the 20th Annual Australasian Society for HIV Medicine (ASHM) Conference, Perth, Australia, 17-20 September 2008 13. Short-Term Clinical Disease Progression in HIV-1Positive Patients Taking Combination. Presented at the 20th Annual Australasian Society for HIV Medicine (ASHM) Conference, Perth, Australia, 17-20 September 2008 14. Patient characteristics and treatment outcomes associated with protease inhibitor (PI) use in the Asia-Pacific region [Abstract #: P_72] Presented at the 9th International Congress on Drug Therapy in HIV Infection, Glasgow, UK, 913 November 2008 15. Short-term risk of anemia following initiation of antiretroviral treatment in HIV-infected patients in countries from sub-Saharan Africa and Asia. Presented at the 14th International Workshop on HIV Observational Databases, Lisbon, Portugal, 25th 27th March 2009 16. Short-term risk of anemia following initiation of antiretroviral treatment in HIV-infected patients in countries from sub-Saharan Africa and Asia. [Abstract #: 200721711] Presented at the 5th International AIDS Society Conference, Cape Town, Africa, 19-22 July 2009 17. Prevalence and Risk Factors of Lipodystrophy among HIVinfected Persons Receiving HAART in the Asia-Pacific Region: Results from the TREAT Asia HIV Observational Database. [Abstract #: H1576] presented at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), San Francisco, California, USA, 16-18 September 2009 18. Non-virological criteria to predict virological failure in TAHOD and IeDEA SA. Presented at the IeDEA Satellite Meeting, San Francisco, USA, 20 February 2010 19. Trend of CD4 cell count in HIV-infected patients with HIV viral load monitoring while on combination antiretroviral treatment. Presented at the The 14th International Workshop on HIV Observational Databases, Sitges, Spain, 5-27 March 2010 20. Impact of sex on long-term treatment outcomes of highly active antiretroviral therapy (HAART) in the TREAT Asia HIV Observational Database [Abstract #: 200736571] presented at the International AIDS Society Conference 2010, Vienna, Austria, 18-23 July 2010 21. Impact of Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) Co-infections on Immunological Responses to HAART in the TREAT Asia HIV Observational Database (TAHOD) [Abstract #: 200739465] presented at the International AIDS Society Conference 2010, Vienna, Austria, 18-23 July 2010 22. High Prevalence of Anal Squamous Intraepithelial Lesions in HIV-positive and HIV-negative Men who have sex with Men in Thailand presented at the International AIDS Society Conference (IAS) 2010, Vienna, Austria, 18-23 July 2010 23. Lack of prophylaxis against Pneumocystis pneumonia and mortality: Results from the TREAT Asia HIV Observational Database (TAHOD) [Abstract #: H213] presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), Boston, USA, 12-15 September 2010

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TASER: The TREAT Asia Studies to Evaluate Resistance (TASER) wasa program to evaluate HIV drug resistance within TREAT Asia clinical centers and to build capacity for HIV resistance testing (genotyping), surveillance of transmission of ARV-resistant HIV, and monitoring the emergence of resistance among thosetaking ARV therapy. The study included 16 participating sites in five countries in Asia, including HIV-NAT/Thai Red Cross (Bangkok), Ramathibodi Hospital (Bangkok), Siriraj Hospital (Bangkok), Chiang Rai University and Chiang Mai University. The study is now closed, but data analyses are ongoing. Data from TASER have been merged into TAHOD. TAQAS: the TREAT Asia Quality Assurance Scheme
(TAQAS) was designed to build capacity and establish external quality assurance for HIV Drug resistance testing. TAQAS was developed as a parallel program to TASER. Proficiency panels include HIV samples derived from HIV-1 subtype B and non-B isolates. TAQAS was first implemented in April 2006, and now continues through a program included sponsored and non-sponsored laboratories. Currently, there are 15participating sites from 6 countries in the Asia-Pacific region, including three laboratories in Thailand: Chulalongkorn University (Bangkok),Siriraj Hospital (Bangkok) and Chiang Mai University (Chiang Mai).

Chaiwatanarat T, Nakavachara P, Maleesatharn A, Chokephaibulkit K. Prevalence and risk factors of low bone mineral density among perinatally HIV-infected Thai adolescents receiving antiretroviral therapy. J Acquir Immune Defic Syndr. 2012 Aug 22. 6. Aurpibul L, Lumbiganon P, Kolasaraksa P, Hansudewechakul R, Sa-Nguanmoo P, Taeprasert P, Bunupuradah T, Pooworawan Y, Sirisanthana V, Puthanakit T. HIV and HBV co-infection among perinatally HIV-infected adolescents in Thailand. Pediatr Infect Dis J. 2012 May 15. 7. Puthanakit T, Bunupuradah T, Kosalaraksa P, Vibol U, Hansudewechakul R, Ubolyam S, Suwanlerk T, Kanjanavanit S, Ngampiyaskul C, Wongsawat J, Luesomboon W, Vonthanak S, Ananworanich J, Ruxrungtham K. Prevalence of HLA-B*5701 among HIV-Infected Children in Thailand and Cambodia: Implications for Abacavir Use. Pediatr Infect Dis J. 2012 Sep 17.

TApHOD presentations are as follows:

1. Regional survey of HIV clinical care resources and management practices in the TREAT Asia pediatric 2. Program. Presented at the AustralasianSociety forInfectious Diseases (ASID) Annual Scientific Conference, New South Wales, Australia, 25-28 March 2009 3. Antiretroviral Therapy Outcomes in HIV-positive Children in Asia: Data from the TREAT Asia Pediatric HIV Observational Database. Presented at the 5th IAS Conference on HIV Pathogenesis, Treatment and Prevention, 19-22 July 2009, Cape Town, South Africa. 4. Impact of antiretroviral therapy on opportunistic infections of HIV-infected children in the TREAT Asia Pediatric HIV Observational Database Presented at the Presented at the International Workshop on HIV Pediatrics, Cape Town, Africa, 19-22 July 2009 5. Antiretroviral Therapy Outcomes in HIV-positive Children in Asia: Data from the TREAT Asia Pediatric HIV Observational Database. [Poster #: MOPEB085] Presented at the International Workshop on HIV Pediatrics, Cape Town, Africa, 19-22 July 2009 6. Survival and Risk Factors associated with Mortality of HIVInfected Children: A Cohort from the AsiaPacific Region. [Poster #: H-927] Presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), San Francisco, CA, USA, 12-15 September 2009 7. Antiretroviral Therapy Outcomes in HIV-positive Children in Asia: Data from the TREAT Asia Pediatric HIV Observational Database. [Poster #: MOPEB085] Presented at the Australasian Society for HIV Medicine (ASHM), Cape Town, Africa, 19-22 July 2009 8. Severe adverse events in HIV-infected children in Asia after first-line HAART. [Poster #: O13] Presented at the 2nd International Workshop on HIV Pediatrics, Vienna, Austria, 1617 July 2010 9. High prevalence of low bone mineral density among perinatally HIV-infected Thai adolescents receiving antiretroviral therapy. [Poster # P_7] presented at the 3rd International Workshop on HIV Pediatrics. Rome, Italy, 15 - 16 July 2011 10. Second-line highly active antiretroviral therapy in Asian HIV-infected children. [Poster # P_37] presented at the 3rd International Workshop on HIV Pediatrics. Rome, Italy, 15 - 16 July 2011

TApHOD: The TREAT Asia Pediatric HIV Observational Database (TApHOD) is a collaborative observational cohort study, which involves 16 participating sites in six countries in the Asia-Pacific region including HIV-NAT/Thai Red Cross (Bangkok), Siriraj Hospital (Bangkok), Chiang Mai University - Research Institute for Health Science (Chiang Mai), Chiang Rai Regional Hospital (Chiang Rai) and Khon Kaen University (Khon Kaen). The primary objectives of TApHODare to:
1. Develop capacity in HIV clinical data collection in the Asia-Pacific region; 2. Assist in evaluation of new pediatric HIV treatments for the Asia-Pacific region; 3. Monitor antiretroviral and prophylactic treatment; 4. Monitor toxicity to antiretroviral therapy; and 5. Examine HIV natural history in children, including the relationship between access to antiretroviral therapy and disease progression. The project was established in 2006 and has enrolled 4,400 patients into prospective follow-up. Sub-studies within the pediatric program have allowed for more in-depth research on specific topics (e.g., bone mineral density, hepatitis B). The program is supported in part by a grant from the U.S. National Institutes of Health andthe Austrian AIDS Life Association.

TApHOD publications are as follows:

1. Prasitsuebsai W, et al. AIDS Patient Care STDS. 2010 Feb;24(2):127-31. 2. Hansudewechakul R, et al. J Acquir Immune Defic Syndr. 2010 Dec;55(4):503-9. 3. Kariminia A, et al. Int J Epidemiol. 2011 Feb;40(1):15-24. 4. Lumbiganon P, et al. J Acquir Immune Defic Syndr. 2011 Apr;56(4):365-71 5. Puthanakit T, Saksawad R, Bunupuradah T, Wittawatmongkol O, Chuanjaroen T, Ubolyam S,

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Education and training

Education Program for Building Research Capacity TREAT Asia implemented a research capacity-building education program with support from the Australian Agency for International Development (AusAID) in 2008. When that program ended in 2011, subsequent training programs have focused on clinical care for children and men who have sex with men, and developing regional research capacity.

PoLicY and communications

The TREAT Asia Report includes reviews of current research activities in the TREAT Asia network and elsewhere in the Asia-Pacific. The report has featured interviews with leading regional and global figures in AIDS treatment, research, and policy. It is produced three times a year as part of TREAT Asias communications activities.

strEngtHEning ciViL sociEtY

To strengthen civil society and community involvement in HIV/AIDS programs in the Asia-Pacific region, TREAT Asia supports activities to provide HIV treatment literacy training, and promote community advocacy for access to optimal HIV treatment regimens. TREAT Asia also supports the Adams Love website, and the development of a parallel website and social media project in Indonesia, called Teman Teman.

gLobaL Fund to FigHt aids, tubErcuLosis and maLaria

This program started in 2006 with the aim to use the Global Fund money to buy antiretroviral therapy and monitoring assays for monitoring CD4 and viral load for patients post clinical trials. HARRT has been shown to effectively reduce HIV related illnesses and mortalities, improving our patients quality of lives significantly. Besides providing ARV therapy to patients, we also collect long term data from each patient participating in the study. ARV drugs, CD4 and viral load tests are supported by Global Fund. Currently, 1424 adults and 321 children receive free ARV drugs, CD4 and viral load tests through the program. Because of the outstanding outcome of this years program, we are currently proposing to the Global Fund to continue the program via the rolling continuation channel.

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sErVicE
Praphan Phanuphak is a member of the Thailand National AIDS Committee and the Vice-Chair of Thailand Country Coordinating Mechanism (CCM) of Global Fund for AIDS, Tuberculosis and Malaria. kiat ruxrungtham is the chair of the Academic Sub-committee on HIVTreatment and Care of the National AIDS Program, National HealthSecurity Office (NHSO); President of the Allergy andImmunology Society, Thailand (AAIAT); a member of the expert panel workinggroup on antiretroviral therapy practice policy guidelines; the Chair of the Research Committeeof the Royal College of Physicians,Thailand. He is also the scientific co-chair of Track A of the IAS HIV Pathogenesis conference will be held in Kuala Lumpur, Malaysia 2013. dr. Jintanat ananworanich is an adjunct faculty member of the Department of Medicine at Chulalongkorn University, University of New South Wales and University of Amsterdam, and University of Hawaii. She has served as Track B committee member for the 2012 IAS meeting in Washington DC and will be Track B co-chair for the upcoming 2013 IAS pathogenesis meeting in Malaysia. She is a scientific committee member for the 2013 ICAAP meeting in Bangkok. She is an organizing committee member for the International Workshop on HIV Pediatrics since 2009 and will serve as co-chair for its 2013 meeting. She is on the scientific advisory committee for the Thai Government Pharmaceutical Organization. She is on the steering committees for the Pediatric European Network for Treatment of AIDS and Treat Asia. She serves on the Scientific Assessment Panel of the HIV Research Trust Award. She is the deputy editor for AIDS Research and Therapy, the editor for Open Virology Journal and a reviewer for various journals such as Lancet, CID, and AIDS. anchalee avihingsanon is a member of the expert panel working group of the Thai Ministry of Public Heath HIV/AIDS management guidelines, a member of the committee of Thai AIDS Society, a member of the expert panel working group on antiretroviral therapy practice policy guidelines, a member of the Thai Royal College of Physicians, an external reviewer for Qualify Ph.D Examination, a member of the working committee on implementing antiretroviral therapy into the universal health care system, the AIDS Division, Ministry of Public Heath and adjunct faculty member of Chulalongkorn University, Faculty of Medicine. She is also a lecturer for local hospitals and international training courses in HIV, opportunistic infections and complications. reshmie ramautarsing is a program coordinator for the Community[e]Education program and a trainer for the HIV[e]Education program, both for the Health[e] Foundation, Amsterdam, The Netherlands. Thanyawee Puthanakit is faculty member of Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, member of the expert panel working group of the Thai Ministry of Public Heath HIV/ AIDS on antiretroviral therapy practice policy guideline, a member of the WHO technical reference group Pediatric HIV/ART care and member of the maternalchild health guidelines development group for WHO 2013 consolidated antiretroviral guidelines. She served as a reviewer for various journals such as the Pediatric Infectious Disease Journal, BMC Pediatrics, HIV medicine. She is the lecturer for pediatric HIV/AIDS. Wasana Prasitsuebsai is a lecturer for local hospitals and international training courses in HIV, opportunistic infections and complications. Wirach maek-a-nantawat is a part-time lecturer at Division of Allergy and Clinical Immunology, Department of Medicine, Faculty of Medicine, Chulalongkorn University, and Centre of Excellence for Biomedical and Public Health Informatics (BIOPHICS), Faculty of Tropical Medicine, Mahidol University. He is also an external examiner for knowledge and thesis defense, Master/Ph.D Program at Mahidol University and Chulalongkorn University, a reviewer for various journals such as Journal of Pediatric Infectious Diseases, Southeast Asian Journal of Tropical Medicine and Public Health and Asian Pacific Journal of Allergy and Immunology.

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www.adamslove.org
Adams Love innovatively combines education and entertainment and is the first website of its kind in Southeast Asia. Adams Love offers an opportunity for MSM in Thailand to access reliable HIV/AIDS-related information from the privacy of thei own homes. In addition to basic facts about HIV risk, testing, and treatment, visitors can access expert advice and online counseling while connecting with other MSM and enjoying entertainment features like photography and celebrity interviews. The websites creative team is now partnering with amfAR to explore initiating a similar edutainment website in Indonesia.

tHE tHai rEd cross aids rEsEarcH cEntrE (trc-arc)

In 2012, Thai Red Cross AIDS Research Centre (TRC-ARC), the mother organization of HIV-NAT, had many achievements and accomplishment which build on its mission to set high standards of patient care, research and community development. Our ongoing activities are as follows.

tHE tHai rEd cross anonYmous cLinic (trc-ac)

The Thai Red Cross AIDS Research Centres Anonymous Clinic is the first HIV voluntary counseling and testing clinic in Asia, established in 1991. Comprehensive health care services are provided to clients regardless of HIV status as entry points to HIV testing according to the provider initiated counseling and testing model (PICT), aiming to reduce stigma of HIV testing. These services include annual health checks, anal and cervical Pap smear, STI testing and treatment and nutritional assessment and counseling.

nutrition cLinic at tHE tHai rEd cross aids rEsEarcH cEntrE

Nutrition services including nutrition assessment and counseling are available every week days at the Anonymous Clinic. The nutrition services are available to people living with HIV who come for follow-up care at the Anonymous Clinic and those who come for health check-up. All clients are screened for nutritional problems by health care providers when they receive any service at anonymous clinic. If they have nutrition problems (i.e. being underweight, obesity, dyslipidemia or hyperglycemia), or are at risk for nutrition problems (i.e. taking nutrition supplement, having any symptom affected by eating), they will be referred to nutritionist for further assessment and in-depth counseling. The nutrition assessment and counseling services aim to promote general health of people living with HIV in the short term and long term through improvement of nutritional status. In the short term, nutrition care aims to prevent weight loss in newly diagnosed HIVinfection. For the long term, nutrition assessment and counseling aim to monitor and prevent the chronic diseases which are commonly found in people living with HIV after receiving ART treatment. Up to 500 clients attended the nutrition clinic in the first half of 2012. Most of which are general clients, particularly Men who have Sex with Men (MSM), who come for health check up.

tHE tHai rEd cross mEn WHo HaVE sEX WitH mEn (msm) sEXuaL HEaLtH cLinic
The Thai Red Cross AIDS Research Centres Anonymous Clinic started providing sexual health services to Men who have Sex with Men (MSM) in 2008. The number of MSM clients receiving the services increased rapidly, leading the Thai Red Cross AIDS Research Centre to officially establish its Mens Health Clinic in June 2009. At the Mens Health Clinic, Voluntary Counseling and Testing (VCT) service for MSM was made even more user-friendly. Staffed with MSM-sensitive health care providers, the clinic is separated from the general VCT service. And the patients get confirmed test results in 3 hours. The Mens Health Clinic provides health services that are of interest for MSM, and serves as an entry point for HIV counseling and testing. Available services include Anal PAP smear, STD screening & Tx, PEP and body composition measurement. Precancerous anal neoplasia (AIN II-III) was found in 18.7% of HIV+ve MSM and in 8.9% of HIV-ve MSM.

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Lao-tHai-austraLian coLLaboration in HiV-nutrition (Lao- tacHin) ProJEct:

After four years implementation (since July 2008), Lao-TACHIN project has completed the first phase in June 2012. Many achievements are seen either improving nutritional status and health of PLHIV directly or improving health service system showed the benefit of integrating nutrition care into HIV service. This model that was initiated in two southern provinces of Lao PDR, Champasak and Savannakhet, has been handed-over to the Ministry of Health Lao PDR to expand to others provinces in Lao PDR. With collaboration with the previous partnership, the Albion Centre (TAC) and Lao partners (Center for HIV/ AIDS and STI, Ministry of Health, Lao PDR, World Health Organisation, Lao PDR and Association of People living with HIV/AIDS) and the new counterpart, World Food Programme, the Thai Red Cross AIDS Research Centre (TRCARC) will provide support to Lao PDR to move forward to the second phase by providing technical assistance and seeking the funds from donors.

The objectives and the key focus areas of work of the centre are: Advocacy, Capacity Building, Research, Information Management and Monitoring and Evaluation. 1. To advocate with governments, academic institutions and civil society organizations the benefit of integrating nutrition interventions for improving the quality of life, health status and medical management of PLHIV. 2. To build capacity of health care staff and civil society organizations to assess the nutrition issues of PLHIV and provide appropriate interventions, care and support. 3. To initiate and coordinate clinical and operational research that includes nutrition for PLHIV and to address the knowledge gap. The Thai Nutrition Taskforce for HIV (TNT-HIV) is a national HIV nutrition committee, appointed in 2008, consisted of Thai experts in HIV and nutrition from various organizations including the Thai Ministry of Public Health, Institution of Nutrition, Mahidol University, and TACHIN. The following HIV nutrition studies are conducted under the TNT-HIV.

TNT-HIV 003 (Trends of morbidity and mortality among Thai HIV-infected and HIV-uninfected patients, a five-year multi-centre, prospective cohort)
The study aims to determine the morbidity and mortality among Thai HIV-infected participants compared to HIV-uninfected participants at the TRC-ARC and the Queen Savang Vadhana Memorial Hospital during 2010 2017. The study has started enrolling 408 HIV-infected participants and 408 HIV-uninfected participants in November 2010. This study has currently enrolled 230 and 237 of Thai HIV-infected participants and HIV-uninfected participants. Among 83 and 55 of HIV-infected participants and HIV-uninfected participants have already follow up in mo 12. The study will complete in November 2017.

Lao-tacHin final workshop, 7-8 June 2012, Vientiane, Lao Pdr. Prof.Praphan Phanuphak, Director of TRCARC (second from the right) and Ms.Charmaine Turton, director international health unit, TAC (the first from the right) presented the trophy of South-South Development Project Award, the award to Lao-TACHIN project from the Global South-South Development Expo of the United Nations held in Rome, 5-9 December 2011, to Lao team leading by Dr. Inlavan Keobounphanh, Deputy Minister of Health, Lao PDR

TNT-HIV 003.1 (Bone Health and vitamin D

status in Thai HIV-1 Infected and Uninfected Adults (A substudy of TNT-HIV 003: Trends of morbidity and mortality among Thai HIV-infected and HIV-uninfected patients: a five-year prospective cohort study) Given the recent interest in the impact of HIV infection on bone health and vitamin D levels and the association of low vitamin D status with several chronic diseases, this study will determine bone health and vitamin D levels, both in HIV-infected population and uninfected population, as a sub-study of TNT-HIV 003. The study has started the enrollment of 70 HIVuninfected participants, 55 HIV-infected with high CD4 and 110 HIV-infected with planned to start HAART in November 2010. This study has now completed the enrollment of HIV-uninfected participants and HIVinfected with high CD4 group. Up to 75 participants or 82.5% of the total participants in HIV-infected with plan to start HAART group has currently enrolled. The study will be completed in November 2017.

asia PaciFic coLLaboration cEntrE For HiV-nutrition (aPcHin):

Working with governments, civil society and partners in Asia and the Pacific to integrate nutrition into HIV programmes: Based on the achievements of TACHIN and LaoTACHIN in Asia, the Asia Pacific Collaborating Centre for HIV Nutrition (APCHIN) was established since June 2012 by three leading organizations in HIV and Nutrition in Asia and the Pacific- TAC, TRCARC and WFP. The centre is hosted at TRC.

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mom tELLs mom LoVEd; an intEgratEd aPProacH oF HiV discLosurE For HiV-aFFEctEd FamiLY
This project is a collaboration between the Italian Red Cross and the TRC-ARC which aims to develop an HIV disclosure model for HIV-affected families in Thailand, to improve the health status communication skill within families, to improve the quality of life and to strengthen the knowledge and capacity, counseling skill and disclosure technique of healthcare workers regarding the Integrated Approaches of HIV Disclosure for HIV-affected Family. The project has completed the staff training for disclosure techniques by disclosure experts, the survey of the readiness and factors associated with health status communication within families, group sessions and Healthy Camp activities. The study will be completed in December 2012. The data from the survey of the readiness and factors associated with health status communication within families have shown that among 367 HIV-infected parents (male 18.8%, women 81.2%), 0.8% already disclosed their HIV status to their children, 14.7% had not yet disclosed but were willing and ready to disclose, 50.4% were willing but not ready, 33.2% didnt want to disclose, and 0.8% didnt respond. Children included 59 boys and 66 girls. Mean (SD) age was 37.5 (5.2) years for parents, 12.0 (3) years for HIV- infected children (n=31), and 11.5 (4.3) years for HIV-uninfected children (n=94).

Parents major concerns for disclosure included fears that the child would be too young to understand HIV and to keep it confidential (47%), the child may be afraid of getting HIV from them (19%), and the child may think of parents as bad persons (9%). Families with uninfected children had significant higher willingness and readiness than the families with infected children (p=0.03). Age 31-35 years (OR=3.06, 95%CI 1.01-15.66, p=<0.01), being male (OR=5.06, 95%CI 1.55-16.50, p=<0.01), and childrens age >17 years (OR=31.48, 95%CI 10.71-92.57, p=<0.001) were predictors of the willingness to disclose. Age 31-35 and 41 years (OR=5.33, 95%CI 1.33-21.36 and 5.18, 95%CI 1.27-27.11, respectively, p=0.02), higher education (OR=2.26, 95%CI 1.26-4.04, p=<0.01), having 3 children (OR=3.15, 95%CI 1.37-7.23, p=0.02), and childrens age >17 years (OR=2.75, 95%CI 1.47-5.14, p=<0.01) were associated with the readiness to disclose. From the survey, we can conclude that more than half of HIV-infected Thai parents were willing to disclose their HIV status to their children. When and how to disclose HIV status without creating negative consequences pose a major challenge. Parental HIV disclosure studies and demonstration models are needed to provide guidance and recommendations in this field.

Standard of Procedure (SOP) of HIV disclosure model

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asian rEd cross and rEd crEscEnt HiV/aids nEtWork (art)

The Asian Red Cross & Red Crescent Task Force (ART) was established in 1994 following the Beijing Decla- ration. Over the years, the name Task Force was informally changed to Network. ART currently has members from 15 South East Asia and East Asia National Societies (NS). At the beginning, the International Federation of Red Cross and Red Crescent Societies (IFRC)s Regional Delegation, Kuala Lumpur served as the Secretariat, this role was transferred to the Philippines National Red Cross following the decision for national societies to manage the Secretariat on a rotational basis. The Secretariat was transferred to the Thai Red Cross in 2000 for three years, then back to the IFRC at the Regional Delegation in Bangkok and Thai Red Cross and currently is ART secretariat hosted and chaired by the Cambodian Red Cross.

In late 2011, The ART Secretariat Office is transferred to Cambodia and ART Website is also hosted by ART Secretariat Office in Phnom Penh, Cambodia. With the support from the Australian Red Cross (ARC) The ARC Volunteer had provided the training to the ART Secretariat Assistant to maintain the ART website. From the 25th to the 26th April 2012 in Borei Angkor Hotel at Siem Reap province, ART Website Development Workshop was successfully conducted by ART Secretariat and trained by ARC Volunteer. The workshop was attended 14 participants including ART members from national societies, ART Chair, HIV/AIDS program staff from Head Quarter and ART Secretariat Assistant. The workshop improved the capacity of the ART members to post articles, reports, photos, videos and other materials related to HIV/AIDS activities to the ART Website in order to promote the ART Website among donors, government, NGOs and organizations.

ART Website Development Workshop 25-26 April, 2012 Borei Angkor & Spa, Siem Reap, Cambodia

Participants testing in login

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tHai rEd cross aids rEsEarcH cEntrE PErsonnEL

administratiVE dEPatmEnt From the left side: Thanachai Ludkrood (Information Technology), Sumitra Techapalokul (Administrative Officer), Vijitra Pradubkaew (Chief of Administrative Department), Somchai Wutthiworakul (Administration Official), Songsri Wiriyawong (Administration Official), Nion Pakawa (Financial), Suphavadee Sangman (Financial), Somchart Thakaeng (Administrative Officer), Sukanya Kaivikaikosol (Housekeeper), Patinya Suriwong (Administrative Officer), Sunanta Intarasuk (Administrative Officer), Ruthairat Pruksasri (Purchasing Officer)

anonYmous cLinic From the left side: Orawan Panichob (Receptionist), Sutthiphong Ploynage (General Service Officer), Prapakorn Koomwan (Medical record Staff), Sureerat Ittichai (Project Coordinater), Radda Pannun (Administrative Officer), Tanujit Rakphan (Psychologist), Charnwit Pakam (Administrative Officer), Patchalee Suttapintu (Educator), Ekkapan Manmon (Project Coordinater), Siripen Areeprayunkit (Finance and Accounting Officer)

LaboratorY From the left side: Tippawan Pankam (Medical Technologist), Samanan Thongyol (Medical Technologist), Watchara Deepum (Medical Technic Assistant), Kannapat Phanjaroen (Medical Technologist), Namfon Sawatwong (Medical Technic Assistant), Alisa Kanbumroung (Medical Technologist)

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tHai rEd cross aids rEsEarcH cEntrE PErsonnEL

sociaL PsYcHoLogY and bEHaVior tEam From the left side: Rangsit Sanguansak (ART Secretariat Programme Officer), Panisa Kaisakulket (Administration Staff), Wannee Khaiwkhaopho (Project Coordinator), Tippawan Sutthikiri (Project Manager), Kamolset Kanggarruer (Senior Professional Level (K 3) Social Work), Thaneth Kanteeranon (Research Assisant) Missing: Somsri Tantipaibulvut (Chief Group of Social Psychology and Behavior), Thaedsak Jumnugsin (Project Coordinator), Sutep Onkumpung (Project Coordinator), Kittapol Thumdee (Project Coordinator) and Jutamart Rojwisatsap (Administration Staff)

sPEciaL task ForcE tEam From the left side: Jureeporn Jantarapakde (Research Dietician and Clinical Trial Program Coordinator), Rosalin Kriengsinyot (Senior Social Worker), Somsong Teeratakulpisarn (Chief of STFT and Program Coordinator), Jiravut Keeratikongsakul (Peer supporter group leader MSM project), Waraporn Sirisakyot (Clinical Trial Assistant), Kanyarat Thonglaem (Data Entry Staff), Kobkun Meepaeng (Clinical Trial Nurse)

sPEciaL task ForcE tEam From the left side: Sumitr Tongmuang (Clinical Trial Assistant), Chayaporn Tasai (Financial Controller and Team Manager), Piranun Hongchookiat (Clinical Trial Nurse), Supabhorn Pengnonyang (Research Dietician, Clinical Trial Nurse and Program Coordinator), Natchaya Kongkaruek (Team Secretary Assistant), Sukanda Sutamkittiwut (Research Dietician), Supaporn Sompoo (Pharmacist Assistant), Pravit Mingkwanrungrueng (Clinical Trial Assistant and Data Entry Staff)

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south East asia research collaboration with Hawaii (sEarcH)

SEARCH is a partnership that began in 2005 with the goal of accomplishing mutual objectives in HIV/ AIDS research and training in the South East Asia region between 3 partners: the Thai Red Cross AIDS Research Centre (TRCARC) and HIV-NAT in Bangkok, the Hawaii Center for AIDS of the John A. Burns School of Medicine, University of Hawaii (UH) at Manoa in Honolulu, and the Armed Forces Research Institute of Medical Sciences (AFRIMS) in Bangkok. SEARCH has 3 co-directors: Professor Praphan Phanuphak (TRCARC), Professor Cecilia Shikuma (UH), and COL. Jerome Kim (AFRIMS). SEARCH is headed by Dr. Jintanat Ananworanich with Dr. Nittaya Phanuphak occupying the role of Deputy Chief.

SEARCH 014: Study of epidermal nerve fiber density, subcutaneous fat and mitochondrial parameters in Thai HIV-positive patients on long-term stavudine treatment and in Thai HIV-negative patients. This study is to compare the density of epidermal nerve fibers in the distal leg and the markers of mitochondrial oxidation in fat tissue and peripheral blood in people who are currently taking d4T and develop numbness with those who do not have numbness and those without HIV infection. About 100 subjects have been enrolled. The study is funded by the US NIH (5 R01 NS063932-02 revised). This study will conclude in 2013. SEARCH 007: HIV-1 specific immune responses in Thai individuals with HIV dementia. This study completed enrolling 60 patients to assess the HIV-1 specific CD4+ and CD8+ T cell responses, and monocyte/macrophage activation and/or dysregulation in individuals with and without HIV-associated dementia prior to and after HAART. Subjects are still being followed at Phramongkutklao Hospital and at SEARCH. The study is funded by the US NIH (R01 NS053359-01A1) and will be completed in 2013. SEARCH 011: Peripheral reservoir of HIV DNA in monocytes pivotal to cognition in HIV. This study completed enrolment of 60 subjects at Phramongkutklao Hospital and at SEARCH. It will determine the long-term relationship between cognition and HIV DNA in circulating monocytes and define the longitudinal relationships between HIV DNA in monocytes and cerebrospinal fluid biomarkers and MRS findings. The study is funded by US NIH (R01 AI075408-01). The study will be completed in 2013. SEARCH 010: Establish and characterize an acute HIV infection cohort in a Thai high risk population. This study has enrolled 77 patients with acute HIV infection (HIV antibody negative, nucleic acid positive) and plan to expand inclusion to 150 subjects to be followed for 5 years. Investigations of the reservoir size, viral sequences and immune responses in the peripheral blood, sigmoid colon, genital secretions and central nervous system are ongoing and some data have been published (Ananworanich J, et al. PLoS ONE 2012; Valcour V, et al. J Infect Dis 2012). The study is funded by the US Military HIV Research Program (MHRP) and by the US NIH (R01MH095613)). Subjects are offered 5 vs. 3-drug HAART under a separate protocol with drugs made available by the Thai Government Pharmaceutical Organization, Gilead, Merck and ViiV Healthcare. There is increasing interest in early-treated acute HIV infection in the context of functional cure and further interventions involving therapeutic HIV vaccine and drugs targeting the HIV reservoir are being planned. In addition, this study has led to the development of the SEARCH 013 study to enroll HIV-negative and chronic HIV-infected controls for comparison of immunologic and virologic parameters with acute HIV-infected subjects.

ongoing cLinicaL studiEs

SEARCH 002: Establishing normal values for neuropsychological testing in Thai. This study completed enrollment of 483 HIV-negative Thai aged 20-79 years old to establish normal values for neuropsychological testing panels. The public can request use of these data via the SEARCH website (www.searchthailand.org). Subjects are enrolled at Phramongkutklao Hospital and at SEARCH. SEARCH 003: Comparing the toxicity profile of a d4T-based regimen as lead-in for the first 6 months versus AZT-based and TDF-based first line regimens. The study completed its 72-week follow up in 150 patients from the TRCARC and Queen Savang Vadhana Memorial Hospital last year. The clinical outcomes (Phanuphak N, et al. Antiviral Therapy, in press) concluded that a 6-month d4T lead-in therapy was safe and could be considered in patients with anemia or low baseline CD4. A second publication (Shikuma CM, et al. HIV Medicine, May 11) demonstrated substantially higher density of epidermal nerve fiber in the distal leg of HIV-infected Thai adults compared published normative data from the U.S, leading to a follow-up study (SEARCH 014, see below) to investigate this further. Analyses on stored samples to decipher the pathogenesis of mitochondrial toxicity and neuropathy are still ongoing. The study is funded by the Thai Government Pharmaceutical Organization and the US NIH (R01 AI074554-01A1 and R01 NS063932-01).

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SEARCH 013: Characteristics of immune cells in gut mucosa of HIV-negative and HIV-positive Thai. This study is enrolling HIV-negative and non-acutely HIV-infected adults to perform immunologic/virologic investigations in the peripheral blood and sigmoid colon for comparison with subjects with acute HIV infection in the SEARCH 010 study. To date 10 HIVnegative volunteers and 5 non-acutely but recently HIV infected volunteers have been enrolled. The study is funded by US MHRP and will conclude in 2014. SEARCH 015: A cohort observational study evaluating predictors, incidence and immunopathogenesis of immune reconstitution syndrome (IRIS) in HIV-1 infected patients with a CD4 count <100 cells/ L who are initiating antiretroviral therapy. This study is to characterize IRIS and investigate the pathogenesis and the outcomes of IRIS. The study has begun enrolment in 2012 at TRCARC and Bamrasnaradura Infectious Diseases Institute. The study is funded by the US NIH and the US MHRP. Improving the diagnosis and management of latent TB in Thai children. This study has completed. It enrolled 158 children with a history of TB contact to assess the sensitivity and specificity of the interferon-gamma release assays and tuberculin skin test in screening for latent TB in HIV-positive and negative children. The study was a collaboration between SEARCH, HIV-NAT, Siriraj Hospital, Queen Sirikit National Institute of Child Health and Columbia University. The study was funded by Tibotecs REACH Initiative Award. HIV vaccine studies in collaboration with AFRIMS and the US Military HIV Research Program: SEARCH will be involved in mucosal compartments investigations for three follow up studies from the RV144 phase III prime-boost ALVAC and AIDSVAX B/E vaccines trial. In addition, SEARCH will be the study site for one of these studies (RV328, SEARCH 016), a study of AIDSVAX B/E vs. placebo in 40 volunteers at low risk for HIV infection to study immune responses in blood and mucosa. The study is anticipated to start in early 2013. MSM research program: SEARCH has a major role in some of the TRCARCs MSM research programs. The study to identifying biomarkers (HPV subtype, p16, MCM proteins, E6 and E7 mRNA) to detect highgrade anal intraepithelial neoplasia among Thai MSM with and without HIV infection has been funded by the IeDEA grant through amfAR and TREAT Asia. The www.adamslove.org is an edutainment interactive website that aims to use social networking as an attractive HIV education and prevention tool. Over 228,000 visitors and more than 40 million hits were recorded since September 2011. SEARCH is also working in collaboration with the World Bank to model the impact, costs and returns on investment of comprehensive prevention in the epidemic of HIV in MSM in Bangkok.

training
SEARCH coordinates training upon request centred around themes including basic and advanced HIV medicine and second line antiretroviral therapy for adults and children. SEARCH has coordinated training programs for PEPFAR Vietnam, WHO India, UNICEF China, Health [e] Foundation and amfAR TREAT Asia. In 2011, SEARCH provided four training courses on the topic of Psychosocial Training to Enhance Treatment Success for Children and Adolescents, supported by the GILEAD foundation and TREAT Asia while a follow up session took place in May 2012. Training courses were provided in Bangkok, Petchburi and Southern Thailand with 40 Thai physicians, nurses, mental health and social workers, attending each of three sessions. The fourth session was an international training session on the same topic for 26 physicians, nurses, mental health and social workers from the TREAT Asia network in Southeast Asia. The international session included lectures, a childrens art camp and field trip activities. SEARCH has been working towards building an infrastructure for NeuroAIDS research in Southeast Asia by providing training and quality assurance in neuropsychological testing to nurses and neurologic examination to physicians. SEARCH holds a regular SEARCH Research Forum to encourage collaboration in NeuroAIDS, acute HIV infection and HIV pathogenesis. In May 2012, SEARCH organized a special lecture on NeuroAIDS. The lecture topics included pathogenesis, clinical manifestations and management of CNS involvement in acute HIV infection. SEARCH studies have shown that DNA predicts cognitive impairment and brain injury in antiretroviral-nave Thais initiating first line therapy. The speakers were Dr. Serena Spudich, an Associate Professor at Yale School of Medicine and Dr. Victor Valcour, an Associate Professor at University of California at San Francisco. In October 2012, SEARCH hosted a mini symposium on the role of secondary lymphatic tissue in HIV-associated immune deficiency and inflammation with lectures from world renowned experts, Drs. Tim Schacker and Jeffrey Chipman from University of Minnesota and Dr. Daniel Douek from the US NIAID Vaccine Research Center.

PEdiatric PsYcHosociaL suPPort actiVitiEs

SEARCH, on behalf of the Thai Red Cross AIDS Research Center, is the recipient of a TREAT Asia Award to conduct a project called Interventions to Promote Retention in Formal School System. The aim of the project is to give support to promote retention in formal school system to children and adolescents who are at risk of or have dropped out of the formal school system and their care givers.

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sEarcH PErsonnEL

From left to right: Michittra Boonchan (Laboratory Technician), Varaporn Pothipala (Business Manager), Somporn Tipsuk (Research Nurse), Puttachard Sangtawan (Research Nurse), Siriporn Nonenoy (MSM Manager), Dr.James Fletcher (Physician)

From left to right: Dr.Jintanat Ananworanich (Chief of SEARCH), Nitiya Chomchey (Clinical Trials Manager), Chayanin Sutthichom (Data Entry), Peeriya Mangyu (Research Nurse), Siriporn Sangthong (Administrative Assistant), Sasiwan Srikhaw (Administrative Assistant)

Missing Persons: Dr.Nittaya Phanuphak (Deputy Chief of SEARCH), Dr.Thep Chalermchai (Physician), Dr.Eugene Kroon (Physician), Ratchapong Kanaprach (IT/Data Manager), Sudrak Lakonphon (Childrens program Manager), Patcharawee Rungrojrat (Monitor), Somprartthana Ratanamanee (Research Nurse), Duanghathai Suttichom (Research Nurse), Sangla Najai (Social Worker Assistant), Chutima Ketbanrung (Social Worker Assistant)

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communitY outrEacH Programs

SUMMARY REPORT OF THE ACTIVITIES FOR HIV-INFECTED CHILDREN AND PARENTS AT THE THAI RED CROSS AIDS RESEARCH CENTRE
Period: October 2011 to September 2012

The Children and Youth Program is a community outreach program under the auspices of the Thai Red Cross AIDS Research Centre (TRC-ARC) and conducted by SEARCH and HIV-NAT, which are subunits within the TRC-ARC in Bangkok, Thailand. The program is supported by three charities: The Born to Live Charity, The ART AIDS Fund and Living and Loving. Due to worldwide economic problems, funding from all three charities has dramatically declined since January 2010. Although nancial support from international sources has been reduced, sponsors have continued to recognise the importance of psychosocial care and currently reassess their funding on an annual basis. The international sponsors have indicated that they would like us to seek increased support from within the country. Staff from HIV-NAT, SEARCH and the Thai Red Cross AIDS Research Centre are therefore engaged in fundraising activities, such as selling T shirts and musical tickets, via The Wish Your Love campaign, in order to allow the Children and Youth Program to continue supporting children and their families. The Programs core mission is to provide psychosocial and nancial support so that children and their families can live and cope with HIV. The Program carries out assessments of childrens psychosocial problems and provides psychosocial support both at the HIV-NAT clinic and during home visits. It provides psychosocial training for health care providers involved in the children care network.

1. The 3rd training in Psychosocial support for children and adolescents Living with HiV For Health care Providers on october 17 21, 2011 in bangkok and Phetchaburi supported by gilead and trEat asia.
A 5-day training session was conducted for 22 persons from 18 organizations:

Country : Cambodia 3 persons, India 2 persons, Indonesia 2 persons, Laos 2 persons, Malaysia 4 persons, Myanmar 1 person, Thailand 4 persons, Vietnam 4 persons Organizations : 15 Hospitals, 2 Non-profit Organization, 1 Private International Association, 3 Social Support Foundations, 1 Research Centre

The Objectives are to understand and learn about psychosocial support interventions which promote treatment success and improve quality of life for children and adolescents living with HIV and to establish pediatric HIV psychosocial support networks within the region.

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The main content of the training session was concerned with increasing knowledge and basic skills in childhood and adolescent psychosocial development, mental health assessments, HIV disclosure counseling, promotion of ARV adherence and promotion of sex education. As part of the training for health care workers from South East Asia, study visits and participatory activities with HIV-infected individuals in the Youth Camp were added in order to reinforce learning points derived from work in Thailand. At the camp, participants were invited to observe psychosocial-related activities to promote ARV adherence and sex education such as art sessions to express themes and issues in youths lives and identities, youth group learning to review and promote understanding regarding HIV and sex education.

2. Sex education in Youth on 17-18 Feb and 16-17 March 2012

10-15 teenagers watched a movie, cooked food, had an informal discussion about lifestyle and spent the night together at the SEARCH office (Tower 2 of The Thai Red Cross AIDS Research Centre). The discussion centred around sex education and that the term describes a lifelong process of acquiring information and forming attitudes, beliefs and values. It encompasses sexual development, sexual and reproductive health, interpersonal relationships, affection, intimacy, body image and gender roles. Sex education should assist young people in developing a positive view of sexuality, provide them with information and skills for taking care of their sexual health and help them make sound decisions now and in the future.

3. Small camp at Baan Khun Yai (Grandmothers Home Camp) on 20-21 March 2012
There were 8 children at this camp, all of whom had just discovered their HIV status. They attended activities learning about the treatment of AIDS and how HIV can be suppressed by combination ARV therapy. The children learned to distinguish between a person who has HIV and a person who has AIDS. They also learned about HIV transmission, how it can be transmitted through unprotected sex and how it can be transmitted from mother to child. They found out how to take care of themselves and how to be healthy with HIV. Three youth volunteers were also present and shared their experiences of how they take care of themselves.

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4. One day activities for children in Kao Din Zoo on 11 April 2012
Children from 4-7 years old had an adventure and practiced painting at the zoo while their caretakers had their own activities. We prepared the caretakers for the process of pre-disclosure. The core message at the event was that AIDS can be treated and HIV can be suppressed by ARV; this was reinforced using the My World book. The caretakers also learnt how to promote child development and build group support.

On 20 April 2012

Children of 8-11 years old and their caretakers who had never before attended a camp visited Kao Din Zoo. They received advice and training in the physical and psychological changes that accompany puberty and learnt about how to look after their health and hygiene as well as broaching the topic of sexual development and sexuality. They also practiced relationship skills and self-esteem, which play a central role throughout our lives.

5. The 4th Training in Psychosocial Support for Children and Adolescents Living with HIV for Health Care Providers supported by Gilead on May 1-4, 2012 in Nakhon Sri Thammarat Province, Thailand.
The children working group found that there are still very few organizations focused on the care of children and adolescents living with HIV in Southern Thailand. Moreover, existing staff and volunteers lack experience in psychosocial techniques. To improve this situation, it is proposed that staff should be supported with further training that emphasizes real-life experience in conducting psychosocial activities for children and adolescents. Consequently, SEARCH organized this workshop in the form of a youth camp at which trainees could take part in working groups, practical sessions and communal leaning. This workshop attracted collaboration and cooperation from the Thai Network of People Living with HIV/AIDS Southern Region (TNP+ Southern) and the AIDS Access Foundation in designing activities and coordinating agencies in the local area.

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A total of 47 participants participated in this workshop: 19 from 6 organizations, 7 from various hospitals and 21 adolescents living with HIV. There were 7 people in each team of trainees, namely: 2 people from the We Understand Group, 2 people from the Youth Volunteer-Child and Youth Project, 2 people from the SEARCH Research Unit and 1 person from the Knowledge Network Institute of Thailand. Participating in the camp training process helps trainees to gain new perspectives and counseling techniques that they are able to take home and apply in their local communities. Specific knowledge gained included an understanding of methods of imparting and developing knowledge about HIV to adolescents that help them to understand the issues more easily as well as factors to consider in the development of group activities. In addition to this, trainees were able to directly observe the changes in adolescents who participated in the activities; for example, the adolescents bonded and became more willing to share their stories and experiences with one another. They also developed an increased understanding of HIV and how they might manage their disease while living a full life and engaging in their communities. All of the adolescents reported satisfaction with and gratitude that they could participate in the activities. They felt that they had gained knowledge about not only HIV, but also other aspects of sex education. They reported that they had had the chance to share their knowledge with the workshop trainees. The adolescents felt this was valuable, and were proud of their participation. They also said that they gained moral support from and made new friends with other adolescents in the camp.

6. Follow-up Workshop on Psychosocial Support for Children and Adolescents Living with HIV, at the Jasmine Executive Suites Luxury Hotel, Bangkok, 16 18 May 2012 supported by TREAT Asia.

The objectives of this session were to enhance the participants knowledge and skills in addressing psychosocial issues involving children and adolescents living with HIV as well as to guide participants in developing psychosocial support plans. The participants consisted of 8 persons from 8 separate organizations who attended the workshop on psychosocial support for children and adolescents living with HIV on 17- 21 October 2011, in Bangkok and Phetchaburi, Thailand. The content of the workshop included a demonstration of group counseling with caretakers on the disclosure of positive HIV status to HIV-infected children and adolescents (children who already knew their HIV status volunteered to take part in these sessions and also helped to provide feedback for trainees) and subsequent practical sessions allowing trainees to develop their own positive HIV status disclosure skills via role play and practice counseling. The participant also had simulated role play and counseling practice sessions with as well as simulated sessions to promote ARV adherence with caretakers of children and adolescents. The workshop also involved group activities promoting sex education in HIV-infected children and adolescents and discussion of the role of caretakers in promoting sex education for HIV-infected children and adolescents. TREAT Asia also provided seed money to help trainees develop and implement similar activities in their home settings.

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7. One day activities on 7 July 2012 support by Standard Chartered Bank.

The children had an opportunity to learn about portraiture and express their feelings by creating their own pictures. After that, they visited the Bangkok Art and Culture Centre. There, the children were able to learn about and try to understand different forms of art as well as become familiar with a number of artworks.

8. Interventions to Promote Retention in the Formal School System supported by a social award from TREAT Asia.
The children and youths enrolled in our program are an average of 12 years old. Of the 87% of children in the formal education system many are not encouraged by their caregivers to pursue higher education. Of the 13% who are not in the formal education system, all did start school but dropped out of school, mostly around grades 3-5 due largely to poor health, caregivers poor attitudes towards HIV/importance of education, HIV stigma and financial difficulties. There is a second peak at grade 9, where primarily poorer students leave to find work rather than continue their studies. We have identified two groups of children and youths who are in need of specific interventions to promote school retention: 1) Children who are currently not in the formal school system. 2) Children who are in the formal school system but are at risk for dropping out or not pursuing higher education

On 27 November 2011
Ten Grade 9 children who are in the formal school system had guidance on educational options by an expert educational counselor. They took an aptitude test and underwent individual counseling and group education.Three older youths also shared their experiences of higher levels of education. The 7 caregivers received guidance with the child on educational options via indivi- dualized counseling involving with the expert educational counselor.

On 10 June 2012
Five children and youths who are not in the formal school system together with 6 caregivers had group discussions. The objective was to promote opportunities for academic study and other skill development as well as to empower the children to reengage in the school system. The content of the discussion included sharing information about the possibilities for and the importance of education and adjusting attitudes towards children and youths living with HIVs academic potential. The children also had sessions aimed at adjusting attitudes towards HIV/AIDS and building understanding about how to deal with HIV stigma. In addition, peers who had reentered non-formal education and continuedto study to university level also attended to share their experiences of education.

On 11 March 2012
Thirteen Grade 10-12 children took an aptitude test and underwent individual counseling and group education with an expert educational counselor. 3 of their caregivers were given guidance on higher educational options by an expert educational counselor.

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On 14 July 2012
Six children and 9 caregivers of children who are at risk of dropping out of school had group discussions to promote the importance of education and intervene with the children. They received information about academic opportunities and discussed the importance of education and adjusting attitudes surrounding the educational potential of children and youths living with HIV.

9. Wai Teen Camp (Youth Camp) on 2-3 August 2012 arranged by Assoc. Prof. Chitsanu Pancharoen and
his team and supported by the Department of Pediatrics at King Chulalongkorn Memorial Hospital.

A total of 25 adolescents and medicals staff attended a one-and-a-half day camp at Nakorn Nayok. Assoc. Prof. Chitsanu, an expert on communication in clinical practice, created the camp so that the teenagers and staff would have a dedicated time to listen to and learn from one another, in an atmosphere that is non-judgmental, understanding and warm. They shared their feelings and developed a closer relationship. The staffs were able to demonstrate their respect for the teenagers, while the youths developed a confidence that the staff were unconditionally fond of them and had their best interests at heart.

10. The book entitled, My World, is published and supported by TREAT Asia
A picture book entitled My World was made to support caregivers in reading or telling stories to children. This book will help children learn about HIV and how to live with the infection. Counselors and related healthcare professionals working with children living with HIV in Malaysia and Indonesia felt that the My World educational booklet would be hugely beneficial for children there and asked for it to be translated into their respective languages. TREAT Asia kindly arranged and covered the cost of the translation and printing of My World into Bahasa Malaysia and Bahasa Indonesia.

My World in Bahasa Indonesia.

My World in Bahasa Malaysia

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ACKNOWLEDGEMENTS
We would like to express our sincere gratitude and heartfelt appreciation to the following Institutional Review Boards (IRBs), without whom these studies would not be possible:

THAILAND
1. Institutional Review Board of the Faculty of Medicine, Chulalongkorn University 2. The Ethical Review Committee for Research in Human Subjects, Ministry of Public Health (MOPH) 3. The Institute for the Development of Human Research Protections (IHRP) 4. Internal Ethics committee, Chiangrai Prachanukroh Hopital 5. The Siriraj Institutional Review Board (SIRB) 6. Institutional Review Board of Bamrasnaraduru Infectious Diseases Institute 7. Committee on Human Rights Related to Researches Involving Human Subjects, Faculty of Medicine, Ramathibodi Hospital 8. Research and Ethic Committee Chonburi Regional Hospital 9. Research and Ethic Committee Queen Savang Vadhana Memorial Hospital 10. Research and Ethic Committee Prapokklao Hospital 11. The Khon Kaen University Ethics Committee for Human Research 12. Ethics Committee Researches Involving Human Subjects, The Bangkok Metropolitan Administration 13. The Ethics Committee Rajavithi Hospital 14. The Ethics Committee Suratthanee Hospital 15. The Research Committee, Faculty of Medicine, Chiang Mai University 16. The Ethics Committee Buddhachinaraj Hospital 17. The Ethics Committee Nakornping Hospital 18. The Ethics Committee Phrachomklao Hospital 19. The Ethics Committee Surin Hospital 20. The Research Ethic Review Committee of Queen Sirikit National Institute of Child Health (Childrens Hospital) 21. The Ethics Committee Sappasitthiprasong Hospital 22. The Ethics Committee Udonthani Hospital 23. The Committee for Research in Human Subject, Department of Disease Control, Ministry of Public Health 24. The Khon Kaen Hospital Committee for Human Research

CAMBODIA
1. Ministry of Health, National Ethics Committee for Health Research

INDONESIA
1. The Kerti Praja Foundation Institutional Review Board, Denpasar, Bali, Indonesia 2. The Ethical Committee of the Faculty of Medicine, University of Indonesia, Jakarta, Indonesia

VIETNAM
The Ethical Review Board for Biomedical Research, Hanoi School of Public Health

Please note that thislist is not exclusivenor exhaustive. Since new research studies are developed and existing studies change, it is possible that some IRBs may not be listed.

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SPONSORS
INTERNATIONAL SuPPORT
Pharmaceutical Partners
Abbott Bristol-Myers Squibb Chiron Corporation Gilead Sciences Matrix Merck & Co., Inc ROCHE Pharmaceutical Tibotec Pharmaceuticals Viiv Glaxo Smith Kline Boehringer Ingelheim

DOMESTIC SuPPORT
Governmental Agencies
Commission of Higher Education, Ministry of Education (CHE) Governmental Pharmaceutical Organization (GPO) Ministry of Public Health (MOPH) National Health Security Office (NHSO) Office of the National Research Council of Thailand (NRCT) Social Security Office (SSO) Thai Research Fund (TRF) Department of Disease Control (DDC) National Research University (NRU)

Academic Organizations

AMC Amsterdam Institute for Global Health Development (AIGHD) Diseases, University of Amsterdam Foundation for AIDS Research, United States (amfAR) The Kirby Institute for Infection and Immunity in Society was formerly known as the National Centre in HIV Epidemiology and Clinical Research, University of New South Wales (UNSW), (Sydney, Australia)

Academic Organizations

Ratchadaphiseksomphot Fund, Faculty of Medicine, Chulalongkorn University

Research Organizations

HIV-NAT Thai Red Cross AIDS Research Centre

Funding Agency

Research Organizations

Pediatric European Network for Treatment of AIDS Swiss HIV Cohort Study

The Aligning Care and Prevention of HIV/AIDS with Government Decentralization to Achieve Coverage and Impact: Project (Global fund Thailand)

Funding Agencies

Bill & Melinda Gates Foundation National Institute of Allergy & Infectious Diseases (NIAID), Division of AIDS (DAIDS), National Institute of Health (NIH)

Charities

Art AIDS Fund Born to Live Charity Living & Loving Charity

Note: Bristol-Myers Squibb provides life-time ATV for some patients. Gilead-Sciences provides Truvada for some patients. ROCHE Pharmaceutical provides life-time SQV for all patients from HIV-NAT 001.4, STACCATO, HIV-NAT 019, T-20, GEMINI, HIV-NAT 017 and HIV-NAT 096. The Aligning Care and Prevention of HIV/AIDS with Government Decentralization to Achieve Coverage and Impact: Project (Global fund Thailand) supports ARV and some CD4 and viral load testing. Please note that thislist is not exclusivenor exhaustive. Since new research studies are developed and existing studies change, it is possible that some sponsors may not be listed.

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Cover Design: Pornwinit Sattayamongkol

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