We propose to establish an AIDS Clinical Trials Unit at Yale University School of Medicine for people living with HIV disease in the City and County of New Haven and the State of Connecticut. This proposal represents an alliance between a small city with a major HIV epidemic and a renowned University with great scientific and clinical strength. The proposed assembles the expertise, experience, resources and commitment of scientists, clinicians and community members, and focuses them on the development and implementation of clinical trials of new therapies for HIV disease. It consists of a clinical core and five optional components in the areas of core virology, core pharmacology, developmental virology, developmental pharmacology and additional developmental research. We anticipate recruiting and enrolling 100 people with HIV disease during the first year of funding. The particular strengths of this application are: (1) The large population of people with HIV disease in New Haven and surrounding areas, which reflects the demography and risk profile of populations previously underrepresented in clinical trials. (2) The existence of over 1600 people with HIV disease who are known to the health care system and are currently receiving HIV related primary clinical care at 8 sites in New Haven and are available for enrollment in clinical trials. (3) The small size of New Haven, close proximity and already existing clinical relationships among these clinical sites which include a NIDA funded TRU, NIAID funded CPCRA, a NICHD funded clinical trials unit and a GCRC. (4) The experience of the PI and other study personnel in the successful performance of large scale studies of HIV disease in women, intravenous drug users and people of color. (5) The active participation of an already organized and broadly representative Community Advisory Board, drawn from the New Haven Mayor's Task Force on AIDS. (6) The presence and participation of a superior diagnostic virology laboratory which currently serves as the national reference laboratory for the VA Hospital system. (7) The expertise of renowned scientists in the areas of pharmacology and molecular pharmacology of antiretroviral agents. (8) Expertise in the areas of statistical and data management of clinical trials, host responses to infectious agents and patient health related behavior.
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