IMMUNOLOGIC AND VIROLOGIC EFFECTS OF PREDNISON ON HIV

Indiana Univ-Purdue Univ At Indianapolis, Indianapolis IN

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Abstract

A Phase II, randomized, placebo-controlled study in which eligible HIV-1 infected subjects on antiretroviral therapy will be randomized to receive study treatment with either prednisone or matching placebo for 12 weeks. Approximately 118 subjects (59 subjects per treatment arm). Eligible male and female HIV-infected subjects who are at least 18 years of age, have a documented CD4 T cell count of 200-600 cells/mm3,a documented plasma HIV-1 RNA result, are PPD skin-test negative, and have been stable on antiretroviral (ARV) therapy with at least TWO agents for minimum of 12 weeks prior to study entry (and who intend to remain on their ARV therapy for study duration) will be eligible. Subjects with a previous history or prior positive skin test to PPD must have completed at least six months of prior preventive therapy for tuberculosis. Concurrent PCP prophylaxis, irrespective of CD4 cell count, must be intiated at study entry if subjects are not already receiving such therapy. Subjects will be stratified upon randomization according to whether or not they are currently receiving a protease inhibitor (PI) as part of their ARV therapy regimen (PI vs.no PI therapy), by screening plasma HIV-1 RNA copy number (<1,000 vs>1,000 RNA copies/ml), and by participation in substudy A5010s (volunteer vs. not a volunteer). Accrual to the higher screening HIV-1 RNA stratum (> 1,000 copies/ml) will be monitored using the monthly monitoring report and an interim analysis of baseline viral load. To ensure accrual of at least 34 subjects into the higher HIV-1 RNA stratum, a limit of 84 subjects will be placed on accrual to the lower HIV-1 RNA stratum (<1,000 copies/ml). Accrual to the lower stratum will close if this limit is reached.