Case Clinical Trials Unit

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DESCRIPTION (provided by applicant): The Case Clinical Trials Unit (CTU) comprises four highly productive clinical research sites: Case/UHC and Metro Health Medical Center in Cleveland, the University of Cincinnati and the Joint Clinical Research Center in Kampala. Each of these four CRS sites is a top performing ACTG treatment trial site with excellent accruals, outstanding performance evaluations and major roles in the leadership of the network and it is scientific productivity. A key theme of this CTU is the close link of our clinical research portfolo with our basic and translational research programs. Thus the four CRS sites of the Case CTU bring a comprehensive research plan to the enterprise. Led by faculty who are national and international leaders in their fields, these units are poised to make substantive contributions to each of the priority areas targeted by the ACTG: Inflammation/End Organ Disease, Cure, Hepatitis and Tuberculosis. The Case/UHC CRS has also been a productive member of the MTN since the network began and proposes to develop studies in the MTN of a highly effective microbicide candidate (5P12-RANTES) that it has been developing for the past 10 years. Both Case/UHC and JCRC sites provide strong rationale for inclusion in the HVTN. Case/UHC has been working with the network on HVTN 505 and has developed a model outreach program more than doubling its enrollment to this high priority HVTN trial. The University of Cincinnati CRS is a highly efficient, well-managed CRS that has been conducting clinical and translational research for the ACTG since 1987. JCRC, the site of the first HIV vaccine trial in Africa, has ready access to large numbers of subjects in well-defined populations at high risk for HIV infection and has the advanced infrastructure to become a powerful contributor to this network. Thus the four CRS sites that comprise this CTU are positioned to provide sustained leadership and contribution to the treatment and prevention agenda of the NIAID Networks.