The objective of the Indiana ACTU is to support and enhance the AIDS Clinical Trial Group in its efforts to develop and evaluate new and better modalities for the therapy of people with HIV infection. In this application we propose to continue our present ACTU at the Indiana University Hospitals and to add a subunit at Methodist Hospital in Indianapolis. The focus of our unit will be enrollment of patients in high priority protocols and, through an aggressive outreach program, enhanced enrollment of persons with HIV infection previously under-represented in clinical trials. Our unit will continue to contribute scientifically, especially in the area of treatment of opportunistic infections such as pneumocystis and histoplasmosis. In addition, we have added resources which will allow us to participate more fully in protocols directed at opportunistic malignancies and AIDS dementia, and allow us to continue to provide high quality data at a relatively low cost. In addition t the clinical trials unit, we are requesting support for a protocol mandated pharmacology core and for developmental research in the following areas: (1) Pharmacology; (2) Immunology; (3) Pneumocystis pneumonia; (4) Anti- fungal therapy. The developmental research in pharmacology will focus on assays for drugs used in HIV infection, on pharmacokinetics, and on drug interactions. The immunology research will focus on surrogate markers of disease progression which can be analyzed by flow cytometry. Developmental research in pneumocystis will focus on strain and antibiotic susceptibility differences in isolates from patients with recurrent episodes of pneumocystis. The focus of the anti-fungal project will be provision of a centralized laboratory which can perform specialized anti-fungal testing required to support clinical trials. It will serve as repository for organisms and specimens and develop and provide antigen detection for histoplasmosis, as well as other fungi.
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