application abstract) This application is for renewed funding of the Howard University ACTU to: a) continue the ACTU at Howard University; b) expand the AIDS Clinical Trials efforts started under the ACTUs at Minority Institutions cooperative agreement funded by NIAID; c) promote minorities participation in AIDS clinical trials; d) conduct ACTG-sponsored research of mutual interest and importance to minorities and the ACTG; and e) explore with the NIAID the feasibility of conducting special studies relevant to minorities, e.g., low-dose oral alpha interferon. Clinical trials will encompass all stages of therapeutic evaluation, with emphasis on phase II (continuing safety/initial efficacy studies) and phase III (definitive efficacy studies). The investigators propose to assist in the development of protocols, recruit patients with HIV infection, coordinate data and specimen collection, maintain quality control of data entry, and collaborate with NIAID and other institutions in ACTG trials. In order to facilitate the recruitment of minorities, the staff includes an outreach worker, and a Hispanic social worker to target the African- American and Hispanic communities, respectively. The overall composition of the staff is intended to reflect the minority populations targeted. Patients will be recruited from hospital clinics, private physicians, and community-based clinics and organizations. Laboratory services will be provided by the Maryland Medical Metpath Laboratory, an ACTG-approved laboratory. Given the available resources at the institution and the population served, the proposed studies emphasize trials of therapies for HIV disease and opportunistic infections. In addition to ongoing studies including ACTG 177, 186 169, 222, 175, 242, and 193A, the investigators plan to add ACTG 260, 261, 277, 223, 251, and 272. The proposed studies will be conducted at the research clinic, which is located directly across the street from Howard University Hospital. The ACTU anticipates enrolling a minimum of 75 patients per year and proposes to increase the present staff by adding a part-time data entry clerk.
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