application's abstract): The AIDS Clinical Trials Unit (ACTU) at the University of Southern California (USC) was one of the original ACTG units funded in 1986. Since its inception, the USC ACTU has accrued a substantial number of women and patients from ethnic minorities. As an example, in 1998, 19 percent of study patients were women and 81 percent were minorities (61 percent Hispanic, 15 percent non-Hispanic blacks, 4 percent Asian, 1 percent American Indian). Research in the area of opportunistic infections (OIs) has been active. During the first two funding cycles, this Unit led the ACTG in the design and execution of studies for the treatment and prevention of OIs. Moreover, accrual for OI studies at USC represented 38 percent of the total ACTG group effort for OI studies. During these same years, the USC Unit also was active in studies of therapies for HA infection. With the decreasing prevalence of OIs, the USC Unit recently has focused efforts to studies of HIV infection, metabolic and neurologic complications, immune reconstitution, and issues relating to women with HIV. In the last funding period, investigators from USC have held AACTG positions (committee and protocol chairs) and have provided leadership to develop studies to investigate the metabolic dysregulation syndromes (abdominal obesity, insulin resistance, lipid dysregulation, and lipodystrophy) that occur in many patients treated with HAART. These abnormalities can predict that patients with HIV will experience excess morbidity and mortality from cardiovascular complications resulting from accelerated atherogenesis and may be serious complications for persons with HIV. It is proposed that investigators from this Unit will provide leadership in developing the scientific agenda of the ACTG that involves emerging problems during the next funding cycle. The Unit at USC also has had a record of patient retention and data management (endpoint determinations, source documentation, and queries) with consistent monthly scores of 100 points for more than 2 years. Finally, USC continues to accrue subjects (in the range of 100 per year) to primary studies. Thus, the applicants propose that USC has the infrastructure to conduct studies that cover many scientific aims and objectives outlined in the Group Application, to provide scientific leadership in a number of important areas, to assure that quality data is transmitted in a timely manner, and thereby to serve as an integral component of the HIV treatment group.
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