Application Abstract): The DUMC would join the ACTG and endeavor to accomplish the common goal of developing and implementing hypothesis-driven, pathogenesis-based innovative clinical trials for persons with HIV infection. The basic and clinical science investigators of Duke University offer to the ACTG a wide array of expertise, collaborative efforts, and a commitment to HIV clinical trials. The proposed basic and clinical investigators have expertise in areas of immune reconstitution/immune-based therapeutics, primary disease therapeutics, treatment and prevention of opportunistic infections (OI), oncology treatment research and neurology treatment research. Duke investigators are especially focused on immune reconstitution through a multidisciplinary collaboration involving immunologists, virologists, gene therapists, hematologist/oncologists and infectious disease physicians. The goals of the current research agenda include the design and testing of strategic interventions that achieve the prolonged suppression of HIV, decrease the HIV burden in lymphoid tissue, and restored immune function. To ensure the integration of the diverse basic and clinical scientific researchers into the Adult ACTU, a local Scientific Advisory Board (SAB) composed of key investigators from these groups will guide the research agenda. The extensive pre-clinical research endeavor at Duke is further complemented by a critical infrastructure for the performance of clinical trials. Over 700 subjects have been enrolled into 50 HIV-related clinical trials at Duke since 1987. The investigators have specifically emphasized their participation in Phase I clinical trials, having participated in the ACTG as a subunit of the University of Alabama at Birmingham (UAB) Adult ACTU since the last ACTG recompetion. Duke University has also maintained an active clinical research agenda outside the ACTG. The proposed catchment area for the ACTU would include the expanding HIV- positive patient population which reflects the Southeastern U.S. HIV epidemic. Seropositive individuals and persons at high risk of HIV infection are catalogued in a clinical database to facilitate subject recruitment. Active outreach programs and the Community Advisory Board (CAB) assist in enrolling women and minorities into clinical trials. The North Carolina Children's AIDS Network (NC-CAN) is coordinated through Duke University and the NC-CAN ACTU is available for collaborative clinical studies for mothers/infants who are HIV exposed/infected. The Adult ACTU will cooperate in fulfilling the mission/objectives of the ACTG. The investigators will initiate and participate in clinical trials of promising new antiretroviral compounds and immune-based therapies designed to interfere with the virus life cycle. Within this context they will endeavor to learn more about HIV pathogenesis and the virologic, immunologic, or host factors that influence clinical outcomes.
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