The primary aims of this proposal are 1) that the UCSF ACTU will continue to provide a major scientific leadership role in the ACTG system with the goal of effectively and efficiently identifying and addressing clinical research questions relevant to improving therapeutic interventions for HIV infection and its associated conditions and 2) that the UCSF ACTU will continue to contribute significantly to the multicenter ACTG effort by the timely and appropriate accrual of patients into trials, collection of high quality data, analysis and publication of this data. The methods for achieving these aims involve the design and implementation of prospective clinical trials with particular emphases on 1) developing new therapeutic agents from initial trials in human subjects to final approval by the FDA and 2) transferring effective therapies from the research setting to routine patient care. The UCSF ACTU contribution to this cooperative effort requires continued support for 1) the cadre of experienced clinical investigators who have developed expertise in trial design, implementation and analysis (evidenced by their scientific and leadership contributions to the ACTG over the past five years) and 2) the highly competent and dedicated, experienced clinical research staff, including research nursing, pharmacy and data management personnel that has demonstrated its capability to efficiently collect data that meets rigorous QA/QC standards. In order to improve generalizability of ACTG trial results to minority and women patient subpopulations, a targeted effort is planned that will improve accrual and retention of these patients in ACTG trials. This effort will include development of an outreach program from the SFGH primary site involving linkages with local CPCRA and NIDA units and community clinics, involvement of a proactive local CAB, addition of investigators with expertise on women's and minority HIV issues, and the addition of a subunit in East Oakland (a primarily African-American community). In order to increase participation in the high priority areas if OI's and neurologic complications, existing subunits with a priority focus in each of these two areas will continue to be employed.
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