HIV/AIDS remains a major health care problem both in the U.S. and throughout the world. The long term goals of the Miami Clinical Trials Unit (CTU), as a member of the AIDS Clinical Trials Group (ACTG) and as an applying member for the HIV Vaccine Treatment Network (HVTN), are to arrest and reverse human immunodeficiency virus (HIV) disease and to prevent infection through vaccine development, with the ultimate objective of curing and preventing HIV. To achieve these goals, we propose to continue our 19 year affiliation with the ACTG Network and to expand our efforts into the high priority area of Vaccine Research Development with the HVTN Network. The Miami CTU brings together investigators with broad and long standing experience in the design and conduct of therapeutic HIV clinical studies, vaccine studies, in prevention behavioral studies, and in the development, evaluation and implementation of immunologic and virologic parameters for the assessment of therapeutic and prevention interventions. The Miami CTU proposes a fully integrated Administrative Core and Clinical Research Site, the University of Miami AIDS Clinical Research Unit (UM ACRU), and therefore will also bring a currently functioning research facility with long-standing expertise and the ability to identify, recruit and follow an infected population and a high risk population for the acquisition of HIV that includes women, minority patients, and injection drug users. With 20 years experience in assessing and following at risk individuals for HIV infection, and the long standing experience and expertise in therapeutic clinical trials, the Miami CTU brings the flexibility and capability to conduct multiple clinical research projects in all phases of development with the ability to rapidly respond to evolving and innovative research. A major strength of the Miami CTU is its proven design, implementation and follow-up capabilities in therapeutic clinical trials. The Miami CTU will continue to contribute and expands its efforts in the treatment and prevention of HIV by: leadership in the design and conduct of HIV-1 clinical studies;actively contributing to the scientific agenda of the ACTG and the HVTN;maintain an average monthly census of 20 study participates over a 12-month period in each clinical trials area of the ACTG and HVTN;provide an expanded clinical capacity to recruit, screen, enroll, and follow no less than 100 study participants over a 12-month period in each clinical trials areas of the ACTG and HVTN;and work with and educate those at risk for HIV and those infected in South Florida. The proposed clinical trials and investigations will advance our understanding of the treatment and pathogenesis of HIV/AIDS, and lead to improved care and prevention of HIV. ADMINISTRATIVE COMPONENT:
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