GHESKIO HIV Clinical Trial Unit

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DESCRIPTION (provided by applicant): GHESKIO (Haitian Study Group for Kaposi's Sarcoma and Opportunistic Infections) in Port au Prince, Haiti is applying as a single site clinical trials unit (CTU) affiliated with two networks, the HVTN and the ACTG. The leaders of the two networks have strongly endorsed GHESKIO's participation. The GHESKIO Centers is a nongovernmental organization dedicated to research, clinical services, and training in HIV/AIDS. Haiti has the highest rates of HIV/AIDS in the Western Hemisphere with -4% of the adult population infected with Clade B HIV-1. Heterosexual transmission predominates with a male to female ratio of 1 to 1. GHESKIO has received 22 years of uninterrupted NIH support including an NIH Merit Award and has over 70 peer-reviewed publications. GHESKIO investigators have conducted landmark clinical trials on the treatment and prophylaxis of HIV-infected patients with tuberculosis and coccidia co-infection. The Haitian Government has designated GHESKIO a "Public Utility", a status reserved for institutions which are essential to the "welfare of the Haitian people", such at the Red Cross. Dr. Jean William Pape is the Principal Investigator of this proposal. He is the Director of GHESKIO, Professor of Medicine at Cornell University, and a member of the US Academy of Science's Institute of Medicine. Dr. Pape is on the ACTG Scientific Steering Committee and is Co-chair of the HVTN Efficacy Trials Working Group. The GHESKIO CTU will continue long-standing collaborations with investigators from Cornell and Vanderbilt Universities. GHESKIO has been a member of the HVTN since 1997 and the ACTG since 2002. It has established the infrastructure and procedures to conduct highest quality clinical trials. GHESKIO recruits volunteers for HIV/AIDS trials from on-site clinics, where 23,000 patients receive HIV voluntary counseling and testing annually. The population is of African descent, -70% female and ~ 25% adolescent. The CTU will provide oversight and centralized clinical research functions such as laboratory, data management, pharmacy, counseling, administration, and finance for the HVTN and ACTG cores and six transition protocols. In 2006-2007, GHESKIO is committed to enroll and follow 630 volunteers in the two networks.