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. The investigators propose to carry out these studies by maintaining the University of Rochester (UR) ACTU within the Adult AIDS Clinical Trials Group (AACTG). In the first year, and in subsequent years, they propose to enroll approximately 192 patients in studies and substudies. They intend to enroll patients into a broad range of types of studies and to maintain an actual to weighted accrual ratio of approximately 0.4 according to the AACTG scheme of protocol difficulty. In addition to enrolling patients into studies supported by all three of the AACTG Research Agenda Committees (HIV Disease, Complications of HIV Disease, and Immunology), they plan to continue contributing to the scientific agenda of the Group by proposing concept sheets and protocols, as well as by participating in committees and working groups. Of particular interest to the UR ACTU within the HIV Disease Research Agenda are studies of initial treatment, treatment intensification, treatment simplification, and treatment of refractory disease, as well as studies exploring viral resistance, eradication, and dynamics. Areas of particular interest within the Complications of HIV Disease Research Agenda are studies related to opportunistic infections, including human papillomavirus (HPV) disease, and neurologic complications. They also plan to contribute to studies within the Immune Based Therapy Research Agenda, including investigations of host mechanisms in HIV disease pathogenesis and immune-based therapies. They will also contribute to the Research Agendas of the Women's Health Committee, the Pharmacology Committee, and the Outcomes Committee.
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