Vanderbilt HIV Clinical Trials Unit

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DESCRIPTION (provided by applicant): The Vanderbilt HIV Clinical Trials Unit (CTU) will consist of an Administrative Component (AC), supporting the HIV Vaccine Clinical Research Site (Vaccine CRS) and the HIV Therapeutics Clinical Research Site (Therapeutics CRS). The long term objectives are to develop an effective: vaccine to prevent HIV infection and to provide HIV-infected patients with new and better therapies to control HIV and it's coinfections as well as to optimize clinical management by minimizing toxicities and complications. The AC will serve several functions: management/overall coordination of the CTU and Leadership Network relationships as well as financial management; scientific coordination and strategic planning; provision of functions and resources shared between the CRSs; leading and supporting community relationships. The location in the epicenter of the epidemic in the Southeast, as well as the proven track records of the proposed investigators and already established research sites provide a strong rationale for this application. "The Vaccine CRS w II continue the outstanding performance of the current Vanderbilt HIV Vaccine Trials Unit. Vanderbilt was included as a preferred site by the HIV Vaccine Trials Network Leadership in their May 2005 submission of a Leadership Network application. The Vaccine CRS will make important contributions to each of the specific aims in the clinical research plan of the proposed vaccine network by enrollment of uninfected volunteers from all risk groups into vaccine trials, expanded recruitment of minority populations, and provision of highly experienced personnel for trials performance and scientific leadership / protocol development for the Network. The Therapeutics CRS will continue the exemplary performance of the current Vanderbilt Adult AIDS Clinical Trials Unit. Vanderbilt was included as a preferred site by the AIDS Clinical Trials. Group Leadership in their May 2005 submission of a Leadership Network application. This CRS will make important contributions to most specific aims of the clinical research plan of the proposed treatment research network. The focus will be on translational research and drug development, as well as optimization of clinical management. This will be facilitated by the Therapeutics CRS's proven ability to enroll H V-infected subjects, a strong plan to further increase enrollment of underserved populations including minoriti3s and subjects from rural areas, established high-quality trials performance, and a record of scientific leadership and accomplishment. Public health will benefit from prevention and better long-term medical treatment of HIV infection. ADMINISTRATIVE COMPONENT: