The primary objective of this proposal is to continue the strong participation of the USC ACTU in developmental therapeutics in HIV positive persons in the priority areas set by the ACTG Central Group Application. This will include participation in Phase I, Phase II, and Phase III studies in the areas of HIV infection, opportunistic infections, immune based therapy, wasting, clinical pharmacology, women's health, oncology, and neurologic complications. This overall objective can be subsumed under several specific aims. The USC ACTU will continue to provide high level expertise and leadership for the ACTG in critical areas of high priority research. With full funding, USC can provide as many as 120 subjects yearly, about 40% in trials of antiretroviral therapy, 40% in trials of HIV complications, and 20% in studies of immune based therapies. Most patients will be enrolled at the Los Angeles County+University of Southern California Medical Center. However, arrangements with Community Based Organizations for referral of patients will ensure the accessibility of ACTG protocols to a wide segment of the greater Los Angeles Community. Patients with the full range of immunodeficiency will be enrolled. These subjects will be of ethnic and gender diversity. Some 50% will belong to minority groups, 35-40% Hispanics, 15-20% Blacks, not Hispanic, and the remainder, White, not Hispanic or other. USC is a site for the Women's Interagency HIV Study, which will facilitate coenrollment of women from this natural history study into ACTG treatment trials. It is anticipated that 16-18% of the total enrollment at the USC ACTU will be women. The patients will be studied in state- of-the-art inpatient and outpatient facilities. An important component is a relocated, remodelled, and modernized General Clinical Research Center. The research at USC will be supported by strong existing laboratory programs in retrovirology, flow cytometry, applied pharmacokinetics, pharmacoanalysis, and viral carcinogenesis and cytokine biology. A separate laboratory area for specimen processing, logging, storage, packing, and shipment also exists. The HIV epidemic continues to spread. HIV and its complications will be important public health problems for decades to come. The USC ACTU will contribute to the rational management of this problem by the development of new treatment modalities to improve survival and quality of life. Coexisting educational programs at the USC ACTU site will also help disseminate knowledge about HIV disease and new treatment programs among health care professionals and the affected community.
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