AIDS CLINICAL TRIALS

This grant request (RFA) is for the establishment (continuation) of an adult clinical trials program for the testing of drugs for the treatment of patients with HIV-1 infection. The major thrust of the trials will be phase II/III protocols to test efficacy of newer types and combinations of antiviral agents to determine the optimal approach to treat early (often asymptomatic), later, (with significant immunocompromised state) HIV (+) patients, as well as those intolerant to current accepted therapy. In addition, protocols for new agents and combinations of agents to treat opportunistic infections, malignancies, and neurological disease associated with AIDS will undergo clinical trials. DEVELOPMENTAL PHARMACOLOGY: Development of novel assays to measure the intracellular levels of AZT to understand the role of acetylation kinetics in sulfonamide intolerance in AIDS patients. DEVELOPMENTAL IMMUNOLOGY: Coordination of soluble cell markers of cellular activation with virus expression by Flow Cytometry of intracellular HIV-1 p24. DEVELOPMENTAL PARASITOLOGY: Study of the growth, detection by Polymerase Chain Reaction, and therapy of Microsporidiosis.