A Georgetown University (GU) ACTU will provide HIV-related clinical trials to the diverse Washington DC community, which has the fifth highest number of AIDS cases, and the second highest prevalence of HIV-infected women of childbearing age in the nation. The GU ACTU is committed to the full participation of women and minorities in clinical trials, and the rigorous investigation of scientific issues impacting HIV drug protocols. As the demographics of the AIDS epidemic have changes, HIV-related clinical trials at GU have increasingly represented African -Americans (52%), IVDUs and women (21%). DC General Hospital and Whitman Walker Clinic will be ACTU subunits, providing increased access to under served patient populations and the ability to offer primary care to all study patients, thereby encouraging recruitment and retention. The subunits are anticipated to enroll 33% of our proposed 150 patients per year. The treatment of HIV lymphoma is an area of special emphasis at GU; the development and application of new chemotherapeutic approaches to HIV associated malignancies will be studied. Maryland Medical Laboratory, Inc, an ACTG approved laboratory, will be responsible for the virology core component. Optional study applications are submitted in the areas of pharmacology, epidemiology and immunology. The pharmacology core support lab has proposed an investigation of factors responsible for adverse drug effects and interactions including genetic and metabolic predictors. A project proposed under C.6 funding will evaluate the influence of psychosocial, biological and medical care factors on adherence and retention in clinical trials, addressing an issue that could affect recommendations for trial designs involving disadvantaged or under-served populations. On-going work in immunology on the control of Mycobacterium avium intracellulare will be extended, focusing particularly on the importance of NK cell function. Data from the optional components will have implications for therapeutics and trial design. Collaboration has been established with the VA Hospital's CPCRA Site, and the HRSA HIV Demonstration project. They will participate with GU and Howard University Medical Center in a combined community outreach program to educate under-represented groups to the advantages and importance of their participation in clinical trials. The Georgetown ACTU application is representative of the expertise existing in Washington, the diversity of our community, and scientific inquiry of a major University Medical Center.
