The University of Alabama at Birmingham (UAB) AIDS outpatient clinic (1917 Clinic) was established in January, 1988, to meet the diverse needs of the HIV infected patients in the State of Alabama and surrounding states, their families, their primary care physicians, and the 85 basic science and clinical investigators of the UAB Centers for AIDS Research (CFAR). The clinic is founded on the philosophy that excellence in patient care delivery is directly linked to the acquisition of new knowledge through research. As such, a major mission of the 1917 Clinic has been to provide state-of-the-art patient care through well-conducted clinical trials. Over the 3 1/2 years of its existence, the clinic has enrolled 444 patients into 26 clinical trials, which focus on both primary infection and opportunistic diseases and range in design from single site, intensive phase I pharmacokinetic studies to multicenter, comparative phase III trials. The demographics of patients enrolled in studies directly reflect the demographics of AIDS cases within the 5 state catchment area, including a high proportion of minority participation (24%) and inclusion of women (10%). A second major goal of the clinic is to link clinical investigation to basic science studies conducted by UAB CFAR investigators. At its inception, the clinic established a computerized clinical database and a specimen repository for all patients evaluated at the clinic. By providing access to these specimens from well-characterized patients, the clinic has enabled CFAR investigators to study questions relating to the in vivo pathogenesis of HIV and the effects of therapeutic interventions on the natural history of disease. This dynamic interaction between the clinic and the laboratory has led to the development of novel surrogate marker assays, which are being applied to ongoing clinical trials, new insights into the mechanisms of nucleoside drug toxicities, and identification of the role mycoplasmas may play in HIV disease pathogenesis. This application proposes to expand the activities of the 1917 clinical trials program and enhance the interaction between the clinic and CFAR investigators through the establishment of an AIDS Clinical Trials Unit at UAB. The presence of a well-orchestrated, already established clinical trails programs; the commitment of outstanding clinical investigators; the dynamic and genuine partnership between the clinic, the patient community, referring physicians, and community based service organizations; the documented enthusiasm of the patient community to participate in clinical trials; and the vital link between the clinic and the basic science laboratories, make UAB an ideal site for the conduct of clinical studies through the AIDS Clinical Trials Group.
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