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:

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
Application #
Study Section
Special Emphasis Panel (ZAI1-BLG-A (M1))
Program Officer
Pouliot, Eileen M
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
University of Cape Town
South Africa
Zip Code
Gray, Glenda E; Mayer, Kenneth H; Elizaga, Marnie L et al. (2016) Subtype C gp140 Vaccine Boosts Immune Responses Primed by the South African AIDS Vaccine Initiative DNA-C2 and MVA-C HIV Vaccines after More than a 2-Year Gap. Clin Vaccine Immunol 23:496-506
Baeten, Jared M; Palanee-Phillips, Thesla; Brown, Elizabeth R et al. (2016) Use of a Vaginal Ring Containing Dapivirine for HIV-1 Prevention in Women. N Engl J Med 375:2121-2132
Moodie, Zoe; Metch, Barbara; Bekker, Linda-Gail et al. (2015) Continued Follow-Up of Phambili Phase 2b Randomized HIV-1 Vaccine Trial Participants Supports Increased HIV-1 Acquisition among Vaccinated Men. PLoS One 10:e0137666
Bekker, Linda-Gail; Johnson, Leigh; Cowan, Frances et al. (2015) Combination HIV prevention for female sex workers: what is the evidence? Lancet 385:72-87
Middelkoop, Keren; Mathema, Barun; Myer, Landon et al. (2015) Transmission of tuberculosis in a South African community with a high prevalence of HIV infection. J Infect Dis 211:53-61
Palanee-Phillips, Thesla; Schwartz, Katie; Brown, Elizabeth R et al. (2015) Characteristics of Women Enrolled into a Randomized Clinical Trial of Dapivirine Vaginal Ring for HIV-1 Prevention. PLoS One 10:e0128857
Siegler, Aaron J; Voux, Alex de; Phaswana-Mafuya, Nancy et al. (2014) Elements of Condom-Use Decision Making among South African Men Who Have Sex with Men. J Int Assoc Provid AIDS Care 13:414-23
Boren, David; Sullivan, Patrick S; Beyrer, Chris et al. (2014) Stochastic variation in network epidemic models: implications for the design of community level HIV prevention trials. Stat Med 33:3894-904
Solomon, Marc M; Lama, Javier R; Glidden, David V et al. (2014) Changes in renal function associated with oral emtricitabine/tenofovir disoproxil fumarate use for HIV pre-exposure prophylaxis. AIDS 28:851-9
Hopkins, Kathryn L; Laher, Fatima; Otwombe, Kennedy et al. (2014) Predictors of HVTN 503 MRK-AD5 HIV-1 gag/pol/nef vaccine induced immune responses. PLoS One 9:e103446

Showing the most recent 10 out of 20 publications