In this application, we propose the constitution of the Sao Paulo Clinical Trials Unit (Sao Paulo CTU), in response to the request for application AI-05-002 "Units for HIV/AIDS Clinical Trials Networks". The Federal University of Sao Paulo (UNIFESP) will be the host institution for this project. The Sao Paulo CTU will be located in one of the most populated cities in the world in a country with a significant HIV/AIDS epidemic. We propose the establishment of three Clinical Research Sites (CRSs): the CCDI CRS, the CRT-DST/AIDSCRS, both proposing affiliation to the ACTG Leadership, and the HVTU Vila Mariana, proposing affiliation to the HVTN Leadership. The Sao Paulo CTU will be under the responsibility of Dr. Esper Kallas (PI), who will oversee the activities of the Unit's Administrative Core with the support of the Executive Committee, the External Advisory Board, and the Community Advisory Board. The mission of the Sao Paulo CTU is to conduct high quality HIV/AIDS clinical research following the highest ethical and data quality standards. To achieve these goals, the Sao Paulo CTU is proposing to adopt the Balanced Scorecard as the Strategic Management System, which consists in a structured reviewing system. This model will allow the Sao Paulo CTU to translate strategy into operational terms, aligning the team to create synergy, and guaranteeing a continuous review of the processes. CCDI CRS is a large outpatient clinic located at UNIFESP. Dr. Ricardo Diaz will be the Site Leader. The Site Leader, his staff and the established infrastructure and expertise is proposing to conduct clinical trials inside de ACTG Network. HVTU Vila Mariana CRS is an already established site for vaccine trials. The Co-Pi and Site Leader, Dr. Artur Kalichman, and his staff have already several ongoing and planned trials, under the coordination of the HVTN Leadership CRT-DST/AIDS CRS will have Dr. Valdez Madruga as a Site Leader. Dr. Madruga and his staff are already conducting trials for the INSIGHT Leadership and has full capability to join the ACTG Network. We are also offering the scientific expertise already in place to investigate different aspects of HIV pathogenesis, therapy, and behavior, which may contribute to the capabilities of the ACTG and HVTN Networks to conduct cutting edge clinical trials in a resource limited country with universal access to antiretrovirals.
|Churchyard, Gavin J; Morgan, Cecilia; Adams, Elizabeth et al. (2011) A phase IIA randomized clinical trial of a multiclade HIV-1 DNA prime followed by a multiclade rAd5 HIV-1 vaccine boost in healthy adults (HVTN204). PLoS One 6:e21225|