Duke University Medical Center will 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 combination of unique expertise, a spirit of collaboration, and an outstanding commitment to HIV clinical trials. The expertise of Duke University basic and clinical investigators coincides with the ACTG scientific agenda in the areas of immune reconstitution/immune- based therapeutics, primary disease therapeutics, treatment and prevention of opportunistic infections, 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 diseases physicians. The goals of our 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 restore immune function. To ensure the integration of the diverse basic and clinical scientific researchers into the Adult ACTU, a local Scientific Advisory Board 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. We have specifically emphasized our participation in phase I clinical trials. This clinical trials infrastructure will interface with the established and newly proposed ACTG operations. Duke University has participated in the ACTG as a subunit of the UAB adult ACTU without interruption since the last ACTG recompetition. Duke University has also maintained an active and successful clinical research agenda outside of the ACTG. Five physician investigators and an experienced staff offer expertise in the design and conduct of clinical trials. An expanding patient population which reflects the Southeastern US HIV epidemic is available for clinical trials participation. All subjects are catalogued in a clinical database to facilitate subject recruitment. Active outreach programs and the Community Advisor Board 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 Pediatric ACTU is available for collaborative clinical studies. Our Adult ACTU will cooperate in fulfilling the mission/statement of work of the ACTG. We 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 we endeavor to learn more about HIV pathogenesis and the virologic, immunologic or host factors that influence clinical outcomes.
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