application's abstract): This application responds to NIH RFA NIAID-98-013. It describes the renewal application of the University of Washington (UW) Adult AIDS Clinical Trials Unit (AACTU). The purpose of the UW AACTU is to perform exemplary HIV/AIDS treatment research in support of the Adult AIDS Clinical Trials Group (AACTG) scientific agenda. UW AACTU was one of 14 original centers funded in 1986 to study therapies for HIV infection. The UW AACTU has made contributions to the AACTG through leadership and participation of its faculty in AACTG committees and protocols, accrual of 1758 patients into AACTG studies, and generation of high quality data. Since 1996, UW AACTU investigators have been members of 38 committees, subcommittees, and focus groups; Chair or Vice-chair for seven of these; Protocol Chair or Co-chair of 23 studies and substudies; and the UW AACTU has enrolled 419 patients in AACTG protocols. The UW AACTU application describes three specific aims: (1) contribute to the pathogenesis-based scientific agenda of the AACTG by providing scientific expertise and leadership in HIV disease, complications of HIV, neurology, immunology, women's health and outcomes; and provide technical expertise to support protocol-mandated procedures; (2) participate in AACTG clinical trials by maintaining the UW AACTUs infrastructure and its experienced staff; enroll 90 patients in main studies and 50 in substudies per year and follow them with a <5 percent loss-to-follow-up rate; and maintain high data quality, quality assurance programs, and a high standard of regulatory compliance; and (3) support special issues of relevance to the AACTG by enrolling patients representative of local demographics; continue an outreach program and partnerships with People of Color Against AIDS Network and Northwest Family Center to maximize enrollment of people of color and women; maintain links with the HIV-infected community, community-based organizations and their network of referring physicians; continue the UW AACTU Community Advisory Board, and provide opportunities for research training of women and minority investigators.
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