Each year there are ~40-60,000 new HIV infections in the United States with ~1.1 million persons living with HIV. There are many important unresolved management issues including the optimal antiretroviral treatment strategy at different stages of HIV disease, treatment of co-morbidities and minimizing of drug-associated toxicities. The University of Cincinnati AIDS Clinical Trials Unit (UC ACTU) has been an NIAID-funded AIDS Clinical Trials Group (ACTG) site since 1987. In this application the UC ACTU proposes to establish a Clinical Trials Unit (CTU) and Clinical Research Site (CRS) affiliated with the ACTG leadership application. This highly-experienced CTU, which was 5th in overall accrual and 3rd in cost per weighted accrual among 34 main ACTG units over the last 3 years, will continue to build upon its exemplary performance, scientific and resource committee contributions to provide leadership within a world-class clinical trials network (ACTG) with the scientific goals of developing new therapeutic approaches (translational research/drug development);optimizing clinical management including toxicities and co-morbidities;preventing maternal-child transmission;and vaccine research and development. To accomplish the goals of the ACTG the UC ACTU will: 1) Establish an administrative core CTU including a principal investigator, clinical trials manager, regulatory manager, data/Quality assurance manager, staff training and education, specimen processing, community outreach and administrative support to provide oversight, coordination and scientific expertise required to operate a high-performing CTU that will interface with the overall agenda/work of the ACTG;2) Contribute to the ACTG scientific agenda by enrolling subjects in studies, generating new proposals participating in study teams and committees to advance the work of the group;3) Establish a CRS that can maintain 20 subjects on study per month with the capability of following 100 subjects annually focusing enrollment on under-represented populations and utilizing the highest standards of good clinical practice for clinical research units. Thus, the UC ACTU, led by Dr. Judith Feinberg, an experienced HIV clinical researcher with support from leading experts in the fields of hepatitis (Dr. Ken Sherman) and HIV associated dyslipidemia/ cardiovascular disease (Dr. Carl Fichtenbaum), will contribute to the improvement in the lives of those with HIV infection through its excellence in clinical research. ADMINISTRATIVE COMPONENT:
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