The objective of the studies described in this proposal is to conduct Phase I, Phase II, and Phase III investigations of new modes of therapy for HIV infection and its complications in a population of patients that reflects the gender and ethniC status of patients with HIV infection in our catchment area. In the first year, we propose to enroll 150 patients in studies and substudies as follows: 40 in Phase I studies, 80 in Phase Il studies, and 30 in Phase Ill studies. We propose to conduct studies in seven general research areas including: (1) primary disease therapeutics, (2) immune based therapy, (3) opportunistic infections, (4) oncology, (5) neurologic disease, (6) women's health, and (7) pharmacology. The main focus of studies conducted by the University of Rochester ACTU would be in investigations of primary disease therapeutics and would include studies of virus load, combination therapy, development of HIV-1 drug resistance, development of HIV-1 quasispecies, novel therapies, and incorporation of new virologic assays into clinical trials. Immune based therapy studies would focus on general immune modulation and HIV-specific immune responses. Efforts in opportunistic infections would be directed primarily towards evaluation of new methods of prophylaxis and investigation of the impact of treatment and prophylaxis on quality of life and utilization of health care resources. The ACTU would contribute to enrollment of patients in oncology studies as well, and would have a particular interest in designing studies of human papillomavirus infections. We also have a strong commitment to studies of neurologic disease, particularly HIV-associated dementia and peripheral neuropathy. Studies performed by the University of Rochester ACTU would also address concerns within the women's health treatment research and pharmacology agendas. We propose to carry out these studies by maintaining the University of Rochester ACTU consortium which consists of the University of Rochester, SUNY Buffalo and SUNY Syracuse. The Principal Investigator is from the University of Rochester, which would continue to serve as the parent unit of the consortium. All core virologic studies would be conducted in Rochester. lmmunophenotyping would be performed by ACTG certified laboratories at each of the three institutions. Procedures to ensure efficient operation of the consortium are well established and have worked effectively for eight years.
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