WASHINGTON UNIVERSITY AIDS CLINICAL TRIALS UNIT

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DESCRIPTION (provided by applicant): This application will continue the contributions of an existing AIDS Clinical Trails Unit at Washington University School of Medicine in St. Louis for the next seven years. We propose a Clinical Trial Unit with an administrative structure led by Dr. David Clifford facilitating active contribution to the AIDS Clinical Trials Group (ACTG) network (100%) proposed in an application responding to RFA AI-05-001 headed by Dr. Constance Benson. We will conduct clinical research by recruiting, screening, and enrolling research participants in trials responding to clinical research plans in the following areas: (1) Translational Research/Drug Development, (-25) (2) Optimization of Clinical Management, Including Co-Morbidities,(~55%) (2)Prevention of Mother-to-Child Transmission(~10%) (4) Vaccine Research and Development. (~5%) and (5) Prevention of Infection (5%). This application describes a single Clinical Research Site (CRS) at Washington University School of Medicine that will carry out all portions of this research agenda. The CRS application includes plans for recruiting, screening, and enrolling 20 subjects in typical protocols in the above research areas, as well as ongoing work supporting continuing trials organized by the ACTG system with in excess of100 participating subjects at the present time. The St. Louis CTU will also contribute to scientific leadership assisting development of translational research with particular emphasis on the co-morbidities including neurologic conditions, hepatitis, cardiovascular and metabolic complications. Additional scientific leadership and expertise will continue to be developed in areas of new HIV therapies and pediatric and adolescent manifestations of HIV disease. Ongoing support for a vital Community Advisory Board will be continued under this application, assuring the constructive engagement for advise and counsel from affected populations, as well as providing outreach and educational support to affected populations. Funding this application will provide for ongoing contributions of the Washington University AIDS research community in translation of critical scientific concepts to optimal implementation to the benefit of all persons with HIV infection. We anticipate improvements in therapy that will improve the health in our own community, country, and in the much larger international community affected by HIV/AIDS. ADMINISTRATIVE COMPONENT: