JHU Southern Asia Clinical Trials Unit
Start Date: 01/01/2007
End Date: 01/01/2013
Johns Hopkins University (JHU) and its partners in Thailand and India are pleased to announce the funding of the JHU Southern Asia Clinical Trials Unit, David D. Celentano, Principal Investigator. This CTU is focused on recruiting injecting drug users and other high risk populations severely impacted by the HIV/AIDS epidemic, into phase IIb and III clinical trials investigating new strategies and methodologies to prevent HIV infection. In particular, we seek to address a high priority clinical research area identified by DAIDS in its RFA-AI-05-002: Prevention of HIV Infection and Microbicides. In the area of prevention of HIV infection we are affiliated with the proposal of the HPTN in response to the linked network RFA. The JHU Southern Asia Clinical Trials Unit consists of an administrative component headquartered at the Johns Hopkins Bloomberg School of Public Health, Department of Epidemiology and clinical research sites in northern Thailand and southern India. In northern Thailand we have a cluster of research sites led by the Research Institute for Health Sciences (RIHES) at Chiang Mai University (CMU) (Thira Sirisanthana, site leader). In southern India we propose the YR Gaitonde Centre for Substance Abuse-related Research (YRG CSAR), Chennai (Suniti Solomon, site leader). All 3 groups have been in the vanguard of HIV prevention research in Asia, with extensive experience dating to the early 1990s, near the beginning of the southern Asian epidemic, and have demonstrated success in recruiting and retaining large cohorts of volunteers and developing and testing innovative methods of prevention. They are led by scientists who are world leaders in HIV epidemiology, prevention, treatment and clinical trials design and include staff who are highly experienced in all key aspects required of clinical trials units and clinical research sites, including: community education, recruitment, retention, clinic coordination, GCP, human subjects protection, data management, specimen tracking and processing, laboratory science and research pharmacy. All 3 groups have previously conducted HIV research funded by the NIH and all have been approved as research sites for one or more DAIDS clinical trials networks. All are highly capable of meeting NIH financial and administrative management standards. The JHU-CMU collaborators have played significant roles in the development of DAIDS network strategies. Dr. Celentano has served as Chair of the Behavioral Sciences Working Group for both the HIVNET and HPTN networks, who prioritized and promoted the establishment of sponsored protocols. Drs. Latkin, Sherman, Lucas, and Apinun Aramrattana are members of the Substance Use Working Group, and Celentano and Thira serve on the Prevention Sciences Committee of the AACTG and HPTN. In addition, Celentano has been a member of the PLG for the HPTN, and Beyrer serves a similar leadership role in the HVTN. Dr. Apinun will serve as the Co-Chair of the Substance Use Working Group for the new HPTN, and will thus be shaping the science agenda for that group for the next 5 years. In addition, Dr. Soloman of YRG CARE has played an active role in the formation of the HPTN. Three HPTN studies are currently under way at the Chiang Mai site and are expect to continue into the period covered by this RFA. HPTN 037, a Phase III behavioral study of the efficacy of a social network intervention in preventing HIV infection among injection drug users, began in Chiang Mai in March 2004; the site has a recruitment target of 600 IDUs and their sexual and injection network members, for a total of 1,740 volunteers. This study was completed in 2006. HPTN 043, a Phase III study of the effectiveness of community based voluntary counseling and testing to prevent HIV infection at a community level, is being carried out in 14 communities in northern Thailand, 7 of which have been randomly assigned to receive the intervention. This study is supported by NIMH but was developed by the HPTN's BSWG; the baseline survey began in January 2005 and is scheduled to be completed in 2011. HPTN 052, a Phase III clinical trial,conducted under an IND, of the efficacy of antiretroviral therapy in reducing sexual transmission of HIV among discordant couples, began enrollment in Chiang Mai in June 2005 with a site enrollment target of 243 couples. A fourth HPTN protocol under development, HPTN 058, began in Chiang Mai by March 2006 addressing the efficacy of opioid substitution therapy with buprenorphine/naloxone and counseling for prevention of HIV infection as compared to detoxification and counseling. Finally, HPTN 063, linking HIV positive heterosexual men and women and men who have sex with men to prevention and care services is to begin recruitment in June 2009.