Cape Town Clinical Trials Unit (CT-CTU) for HIV/AIDS Prevention & Treatment

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DESCRIPTION (provided by applicant): The Cape Town Clinical Trials Unit (CT-CTU) is applying to become a DAIDS Unit for HIV/AIDS Clinical Trials. The administrative unit for the CT-CTU is based in the Desmond Tutu HIV Centre (DTHC) at the University of Cape Town (UCT) under the leadership of Professor Robin Wood, one of South Africa's leading experts in HIV care and treatment. The CT-CTU also includes expertise from the Infectious Diseases Epidemiology Unit and the Departments of Virology and Psychiatry at UCT. The CT-CTU is comprised of three Clinical Research Sites (CRSs) located within 10 miles of the DTHC, each applying within a single DAIDS Network priority area. The Nyanga CRS is led by Dr. Linda-Gail Bekker and is focused on Vaccine Research and Development with special emphasis on adolescents. The Gugulethu CRS specializes in Phase II and III clinical trials of Microbicides and other HIV Prevention interventions and is led by Dr. David Coetzee. The DTHC CRS, led by Professor Wood, has a long history of successful trials of antiretroviral therapy and is focused on the optimization of clinical management including co-morbidities. Each of these sites has a strong track-record in multisite HIV clinical trials, including a staff complement already in place to initiate research activities within 6 months of the grant award and maintains active Community Advisory Boards, which drive community involvement in clinical research. These Clinical Research Sites will be supported by a centralized Administrative & Scientific Core providing technical support in administration and finance, laboratory systems, data management, and training and regulatory requirements. This core, based at the DTHC, will maximize efficiency in the set-up and conduct of clinical trials at each CRS. The operations of the CT-CTU are greatly simplified by the location of all administrative and management structures within the University of Cape Town. In addition, this application features a Mentoring Partnership application linking the Nyanga CRS with the HVTN CRS of the Perinatal HIV Research Unit in Johannesburg, South Africa. This partnership will strengthen the capacity of the Nyanga CRS to conduct Phase I, II and III HIV vaccine trials through training and technical support, building on the already strong relationships between these two centres developed through collaboration in the NIH-funded CIPRA-SA grant. ADMINISTRATIVE COMPONENT: