This ACTU site plans to continue to be an active participant in HIV clinical trials. One hundred patients per year emphasizing earlier phase trials will be enrolled. It is proposed that this site will enroll 15 patients per year into phase I studies, 20 patients per year into phase I/II studies, 25 patients per year in phase II studies, and 40 patients per year into phase III clinical trials. The focus of the investigations will be influenced by the nature of the patients seen at the institution and available for ACTG supported studies. This patient population is ideal for the study of primary antiretroviral therapy in patients with advanced disease or for studies of newer agents for opportunistic infections. The number of patients is anticipated to continue to grow, making this institution capable of enrolling patients in multiple clinical trials. The principal focus of primary infection studies will be on newer therapies, particularly in advanced disease. Phase I and/or phase I/II studies in such patients are planned followed by combination therapies. Combining immunomodulators with primary antiretroviral studies is proposed. Studies in opportunistic infections will concentrate on the development of new agents for acute infections. The Gastroenterology and Pulmonary collaborators will facilitate studies of new therapies involving those organ systems. The Oncology co-investigator will facilitate studies of the therapy for HIV-associated malignancies. The Neurology collaborator will guide participation in studies of therapies aimed at neurologic complications of HIV infection or opportunistic infections involving the nervous system. Development of a collaborative group from multiple disciplines which will focus on development of new therapies for HIV infection and opportunistic infection will provide a broad range of expertise. Innovative protocol development will be a priority of this study group whose goal is to improve therapeutic options available to patients as quickly as possible.
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