Phase I/II trial of the anti-HIV activity of mifepristone in HIV-infected subjects ACTG 5200.

Journal of Acquired Immune Deficiency Syndromes : JAIDS
Michael F ParaACTG A5200 Team of the ACTG

Abstract

Mifepristone is a glucocorticoid receptor inhibitor shown in vitro to have anti-HIV activity and anti-simian immunodeficiency virus activity in a macaque model. A phase I/II trial was performed to assess the drug's safety and anti-HIV activity. A 28-day double-blind, placebo-controlled trial of mifepristone at doses of 75 mg, 150 mg, and 225 mg given daily was conducted in HIV+ persons with CD4+ lymphocyte counts >or=350 cells per cubic millimeter who had no recent antiretroviral therapy. Fifty-six male and 1 female subjects with a median entry CD4+ lymphocyte count of 555 cells per cubic millimeter and plasma HIV-1 RNA of 15,623 copies per milliliter were accrued. Forty-five subjects (78.9%) were available for endpoint analysis. In each arm, changes from baseline to day 28 in plasma HIV-1 RNA and CD4+ lymphocyte count were not significantly different from zero (no change). There was no relationship between mifepristone trough concentrations and plasma HIV-1 RNA. Day 28 morning plasma cortisol levels were significantly higher in the 150 mg and 225 mg arms compared with placebo, confirming biologic activity, and returned to baseline by day 56. Serum lipids did not change during the trial. Fasting blood sugar was 2.5 mg/dL higher...Continue Reading

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Citations

Oct 1, 2011·Future Microbiology·Matthew S Miller, Joe S Mymryk
Dec 20, 2018·The Cochrane Database of Systematic Reviews·Haneefa T SaleemCaitlin E Kennedy
Jan 14, 2021·Biochemical Society Transactions·Alexander J Martin, David A Jans

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