Johns Hopkins University-Guangxi, China Clinical Trials Unit

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DESCRIPTION (provided by applicant): Leading HIV investigators from the Johns Hopkins University (JHU) - Guangxi China Center for Disease Control and Prevention (CDC) Collaboration propose a Clinical Trials Unit (JHU-Guangxi China CDC CTU) for the purpose of conducting clinical trials at two well developed clinical research sites in Manning City and Heng County in the Guangxi autonomous region of China. This region, which borders Vietnam, has the third largest number of HIV infected persons in China. The JHU-Guangxi China CDC CTU proposes to conduct clinical trials in 3 priority areas: 1. Other HIV prevention trials particularly among intravenous drug users (IDUs) as an affiliated HPTN CTU at the Heng County clinical research site; 2. HIV Vaccines at the Nanning clinical research site; 3. Optimization of clinical management including co-morbidities (HIV infected adults and children) at the Nanning clinical research site. The Heng County clinical research site was shown to have an HIV seroprevalence rate of 25% and seroincidence rate of 3.1% in HPTN 033 among 500 IDUs and is scheduled to begin a Phase III randomized suboxone intervention trial among this IDU population to prevent HIV infection. The Manning clinical research site is currently conducting the first Phase I HIV Vaccine trial using a Chinese developed HIV vaccine and has the largest HIV ARV treatment clinic in Guangxi province. A well developed infrastructure is already in place including a CAB, IRB, an FWA, a data management center with the SCHARP DATA FAX system, sophisticated laboratory capabilities (including CD4, viral load, HIV sequencing), pharmacy, and study staff with GCP training to support these sites. The principal Investigator (PI) of the JHU-Guangxi CDC CTU will be Brooks Jackson, MD, MBA based at JHU, and the Co-PI will be Liu Wei, MD of the Guangxi Center for HIV/AIDS Prevention and Control (GXAIDS), based at the Guangxi CDC Manning, China. JHU will be the primary applicant organization which will subcontract with the Guangxi CDC those costs to conduct clinical trials at the clinical research sites. ADMINISTRATIVE COMPONENT: