Case Western Reserve University proposes to establish a Clinical Trials Unit (CTU) with clinical research sites (CRSs) at Case/University Hospitals of Cleveland (UHC), MetroHealth Medical Center in Cleveland and the Joint Clinical Research Center (JCRC) in Kampala, Uganda. These three sites have been invited to join the AIDS Clinical Trials Group (ACTG);the Case/UHC CRS as the lead site of a highly productive microbicide development program has also been invited to join the Microbicides Treatment Network (MTN) and though not formally invited, the Case/UHC CRS and the JCRC CRS propose participation with the HIV Vaccine Trials Network (HVTN) in trials of HIV vaccines. The AIDS Clinical Trials Unit (ACTU) at Case has been continuously funded as part of the ACTG since 1987. In this period, the Case ACTU has had a stellar record of clinical trials performance. As a recent example, this ACTU was ranked #2 in total accruals to ACTG trials in the past three years and has always met or exceeded expectations in all aspects of clinical trials performance. The overriding theme of the Case CTU is to bring to the clinical trials research agenda the fruits of basic and translational research that is ongoing at our institutions. Established scientific strengths of the unit have been in the arenas of immunologic monitoring, vaccine and other immune based therapeutic studies, studies of hepatitis C infection and of the metabolic complications of HIV disease. Not surprisingly therefore, Case with its subunits at UHC and MetroHealth Medical Center has been ranked #1 in scientific contributions to the ACTG over the past three years. With a more than 17 year history of scientific collaboration with clinicians and researchers in Uganda that includes the development of a sophisticated and productive laboratory and clinical trials research infrastructure at the JCRC, inclusion of this CRS as a member of the Case CTU is reasonable. As Case investigators are leading the AIDS Malignancy Consortium (AMC) international research effort and also are leading the Oral HIV Research Alliance (OHARA), the Case CTU will help bring together clinical and laboratory researchers from diverse disciplines to address in collaboration the most compelling questions in HIV research and care in the United States and in the developing world. ADMINISTRATIVE COMPONENT:
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