This year there are a total of 83 studies. There are 3 pharmacokinetics studies, 14 viral studies, 6 TB studies, 7 long-term cohorts, 6 strategic studies, 21 new drugs studies 5 sexual health studies, 8 other studies and 12 pediatric studies. 2 PK studies are ongoing and 1 was completed this year. There are 8 ongoing viral co-infection studies, 5 studies were opened late last year or early this year, and 1 study was closed. As for the TB studies, there are 2 ongoing studies, 1 study just started and 3 were completed. All of the cohort studies are ongoing. For the strategic studies, there are 3 ongoing studies, 1 new study and 2 completed studies. This year we have many new drug studies. 7 IND studies were opened recently and 13 studies are still ongoing. 1 IND study was completed this year. There are 2 new sexual health studies, 2 completed sexual health studies and 1 ongoing sexual health study. There are 4 ongoing studies in “other” fields, 1 opened recently and 3 completed. For the pediatric studies, there are 7 ongoing studies, 3 opened recently and 1 completed.
Number of studies in 2013 vs 2014
Key to abbreviations
Clinical Research Programs in Co-Viral and Viral Infections
Clinical Research Programs in HIV/TB Co-Infections
Long Term Cohort Analysis
New Drug Development
Expanded Access Programs
Sexual Health Studies
Pediatric and Youth Research Programs
This year has been good for liver diseases, especially for HCV, worldwide as well as for HIV-NAT. In terms of HCV research and treatment, we are now embarking into a new exciting era that promises shorter treatment duration, fewer side effects/toxicities, and therapies consisting of all oral, direct-acting, powerful antiviral agents. Two new drugs, sofosbuvir (first new class nucleotide polymerase inhibitors) and simeprevir (a second-generation protease inhibitor), were approved by the US FDA at the end of last year. But we continue to have problems with the pricing of these drugs as in many parts of the world. The other problem is that we do not have access to the new drugs due to both patent protection and voluntary licenses. It is unfortunate that Thailand have been left off the list to acquire generic sofosbuvir. Nevertheless, we are working diligently with Gilead, NGOs and the Thai FDA to help bring this drug to our patients. Since we have a great relationship with all of our partners and collaborators, we are very hopeful that we will be able to accomplish this soon. We are grateful that Gilead is going out of its way to assist us with this.
As for HCV research, we are happy to inform you that after a few years of stagnant activity and frustrations, we have finally been able to put this into motion at the end of last year! Since then, we have launched a total of 3 large HCV studies with the Treat Asia, National Health Security Office (NHSO) and The Aligning Care and Prevention of HIV/AIDS with Government Decentralization to Achieve Coverage and Impact: ACHIEVED Project (Global Fund Thailand). We are extremely proud of Dr. Anchalee Avihingsanon who has pushed for free HCV tests and HCV treatment for all HIV-infected patients. Starting this October 2014, HCV tests will become available once per year to all Thais through the national health care program. Now she is working on getting the national health care program to legally enforce all physicians to routinely test for HCV in all HIV-infected patients, especially among high risk groups such as MSM, IVDUs, and prisoners. She wants to expand HIV’s strategic method of Treatment as Prevention (TasP)/Test and Treat to other infections such as HCV, HBV and TB. We are currently looking for sponsors and collaborators to help launch this very important and necessary study.
Aside from this, her persistence has paid off in making sure that HCV treatment, peg IFN and ribavirin, is available to all HIV co-infected patients through the national health care program. For the first time in the history of Thailand, she managed this by bringing in the pharmaceutical companies, members from the Thai liver association, members from the Thai AIDS Society, members from the Thai Infectious Disease Association, various NGOs and policy makers to meet with each other for a whole day to discuss the way forward for HCV treatment. This meeting was supported by the TREAT Asia and was well received by the community. This is a huge accomplishment for HIV-NAT because this type of meeting has never before been set up. In addition, HCV, unlike HBV, is curable so that is the main reason why Dr. Avihingsanon is pushing hard for universal HCV treatment through the national program. HIV-NAT is currently the only center in Thailand that can provide HCV treatment without having a GI doctor. Other centers are required to have at least one GI and one ID doctor and more than 5 years’ experience in hepatitis in order to be able to provide free HCV treatment to its HIV co-infected patients. And she has not stopped there. She is now working with the pharmaceutical companies, NGOs and the Thai FDA to get newer HCV drugs into the national health care program.
Dr Avihingsanon is currently a member of the hepatitis group for the ACTG and is the only member from Asia to participate in this network. More greater things for HCV are expected to come out of this collaboration. As for HBV, HIV-NAT is working to be a pioneer for HBV cure with its Australian partners.
This year has been equally great for HIV too. Working with RIHES, our first ACTG study A5279 successfully completed its enrollment at the time of writing this. We are extremely grateful for RIHES’ help and mentorship otherwise this would have not been possible. The next study A5288 is set to open in Dec 2014 and the staff are currently preparing documents for another study that is currently in the pipeline for next year.
This year has been quite busy for the pediatric team as well. They have launched two large NIH studies: the Resilience and Latent Reservoir studies. The Resilience study will identify critical determinants for resilience or competency of adolescents’ cognitive, emotional and behavioral functioning at times of adverse circumstances/events. Resilience has not been studied in adolescents living with or affected by HIV. This study will be done with our partners from the PREDICT study. This study will also assess the neuroanatomical areas of the prefrontal cortex that contribute to the risk taking behaviors and resilience in adolescents. We will compare this data with those done in the US and South African adolescents. We hope that the information gathered from this study will help us create a better preventive intervention that will successfully promote health in HIV-infected youths worldwide to smoothly transition into the work force. Recruitment of patients will begin next year.
The Latent Reservoir study will also be done with our partners from the PREDICT study and various divisions of the Ministry of Public Health, Thailand including the National Health Security Office (NHSO). This study will assess the amount of latent reservoirs in infants who have started HAART before and after 6 months of age. This study is important because it will inform us when we can have an ART holiday/strategic timing interruption (STI) and the length of this interruption in the pediatric population without compromising the patients’ health. We will start to enroll the patients early next year. We will have to wait for 2021 to get the results from both of these very important and exciting studies.
HIV Research Trust scholarship was awarded to Ms Narukjaporn Thammajaruk for 2014. She worked at Dept of Pharmacy and Nijmegen Institute for Infection, Inflammation and Immunology on TB drug rifampicin PK for 1 month. At the time of writing this, two of our staff have submitted their applications for the HIV Research Trust scholarship 2015. Another staff, Dr Vorapot Sapsirisavat, was awarded the amfAR scholarship for 6 months (Jan – June 2014) at the University of Pittsburg. Through this program, he even got “FAITH” funded. In brief, the FAITH study will investigate the factors that contribute to unknown HIV seropositivity among high risk MSM in Bangkok and to see whether we can influence the HIV testing pattern based on this knowledge. The study has been set to start early next year. In addition, a pediatrician from Faculty of Medicine, Chiang Mai University, and RIHES chose to do her one-year research with HIV-NAT. Dr. Tavitiya Sudjaritruk was awarded the Collaborative Initiative for Paediatric HIV Education and Research (CIPHER) Grant Programme for the Liver and Metabolic Complications study (HIV-NAT 203).
That is just a little glimpse of what we have been doing in 2014 and what more we can expect to come in the near future. As part of the humanitarian research organization, we will continue to transfer knowledge to both professional health care workers and the community, do our best to help our patients have a better quality of life and health, have access to essential medicines, reduce the incidence of HIV infection to zero or close to it, destigmatize HIV, contribute to the development of the HIV treatment guidelines, and conduct high quality, clinical research studies to answer gaps of knowledge in the field of HIV.
Overall Thai Support
number of studies
Commission of Higher Education, Ministry of Education (CHE)
Ministry of Public Health (MOPH)
National Health Security Office (NHSO)
National Research Council of Thailand (NRCT)
Social Security Office (SSO)
National Research University Grant (NRU)
Department Disease Control (DDC)
Government Pharmaceutical Organization
The Aligning Care and Prevention of HIV/AIDS with Government Decentralization to Achieve Coverage and Impact: ACHIEVED Project (Global fund Thailand)
Thai Red Cross AIDS Research Centre
Overall International Support
number of studies
National Institute of Health (NIH)
The National Health and Medical Research Council (NHMRC) Australia
Merck & Co., Inc
Janssen-Cilag International NV
Foundations for AIDS Research, United States (amfAR)/TREAT Asia
The Kirby Institute for Infection and Immunity in Society, University of New South Wales, Sydney, Australia
Pediatric European Network for Treatment of AIDS (PENTA)
The Collaborative Initiative for Paediatric HIV Education and Research (CIPHER) Grant Programme
Bill & Melinda Gates Foundation
Art AIDS Fund
Please note: This list is not exclusive nor exhaustive, since new research studies are developed and existing studies change, it is possible that some funders may not be listed.