The Ohio State University (OSU) AIDS Clinical Trials Unit (ACTU) plans to conduct clinical research that will increase knowledge about the pathogenesis, prevention, course, and treatment of HIV infection and its associated complications through affiliation by prior agreement with the AIDS Clinical Trials Group (ACTG) led by Dr. Constance Benson of the University of California, San Diego, CA and also proposes to affiliate with the HIV Vaccine Trials Network (HVTN) led by Dr. Lawrence Corey of the University of Washington, Seattle WA. Clinical trials will be designed and implemented: 1) to optimize the clinical management of HIV and its related complications;2) to evaluate agents with novel mechanisms of action or improved toxicity profiles for the treatment of HIV and/or for major copathogens (such as tuberculosis and hepatitis);3) to evaluate the safety, immunogenicity, and efficacy of multiple candidate HIV vaccines and adjuvants;4) to develop means of reducing HIV transmission by integrating HIV treatment with prevention efforts that evaluate practical behavioral interventions and other methods of transmission interruption;and 5) to minimize the risk of vertical transmission by maximizing care of HIV-infected women during their child-bearing years. HIV-infected individuals from a wide spectrum of ages, communities and socio-economic conditions will be recruited, screened and enrolled in specific protocols that address these high priority research areas at the OSU ACTU. Coordination of research related activities and timely execution of new studies will take advantage of established investigator expertise, ongoing productive partnerships with scientist colleagues and the HIV-infected community and a clinical research infrastructure that is recognized for its productivity in the ACTG over the past 18 years and more recently in large scale vaccine and prevention trials. Experienced research staff (investigators, nurses, pharmacy, data management, laboratory and outreach personnel) will recruit, screen, enroll and rummage all essential and required elements of clinical trials participation. Clinical research that develops and tests strategies and new treatments for HIV infection and its complications is critically important for controlling HIV disease progression and minimizing side effects. Well-designed clinical trials to test vaccines and other preventive strategies are essential to preventing the spread of HIV infection. ADMINISTRATIVE COMPONENT:
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