Phase II study of the antiretroviral activity and safety of the glucocorticoid receptor antagonist mifepristone in HIV-1-infected patients

Donia,Marco; Anzaldi,Massimiliano; Di Marco,Roberto; Libra,Massimo; Mangano,Katia; Fagone,Paolo; Galvagna,Salvatore; Di Gregorio,Pietro; Nicoletti,Ferdinando

doi:10.3892/ijmm.2011.703

September 2011 Volume 28 Issue 3

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September 2011 Volume 28 Issue 3

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Article

Phase II study of the antiretroviral activity and safety of the glucocorticoid receptor antagonist mifepristone in HIV-1-infected patients

Authors:
- Marco Donia
- Massimiliano Anzaldi
- Roberto Di Marco
- Massimo Libra
- Katia Mangano
- Paolo Fagone
- Salvatore Galvagna
- Pietro Di Gregorio
- Ferdinando Nicoletti
View Affiliations / Copyright

Affiliations: Department of Biomedical Sciences, University of Catania, Catania, Italy, Department of Biomedical Sciences, University of Catania, Via Androne 81, I-95124 Catania, Italy
Pages: 437-442
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Published online on: May 20, 2011

https://doi.org/10.3892/ijmm.2011.703
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Abstract

Preclinical studies have shown that the anti-glucocorticoid drug mifepristone effectively inhibits HIV replication both in vitro and in vivo. However, the drug did not demonstrate anti-HIV activity in a previous phase I/II study when administered at the daily dose of 75-225 mg. The aim of this study was to assess whether mifepristone may exert antiretroviral activity or influence immunological parameters when administered orally at daily doses of 150 or 300 mg in highly active antiretroviral therapy (HAART)-naïve HIV-infected patients. We performed an open label non-randomized phase II study that included 26 patients who underwent 28 days of once daily oral administration of 150 (12 subjects) or 300 mg (14 subjects) of mifepristone. A total of 3 patients dropped out of the study, respectively 1 in the 150 mg dose group and 2 in the 300 mg dose group. The main hematochemical alterations reported were hypokalemia and increase in the blood levels of cortisol, especially in those patients that received mifepristone at the dose of 300 mg/day. Although we observed a trend of reduced viral load along the study in both groups, statistical significance was not achieved for either the primary nor the secondary endpoints. In summary, mifepristone treatment was well-tolerated but it failed to significantly influence viro-immunological parameters in HAART-naïve HIV-infected patients.

Journals

International Journal of Molecular Medicine

International Journal of Oncology

Molecular Medicine Reports

Oncology Reports

Experimental and Therapeutic Medicine

Oncology Letters

Biomedical Reports

Molecular and Clinical Oncology

World Academy of Sciences Journal

International Journal of Functional Nutrition

International Journal of Epigenetics

Medicine International

Phase II study of the antiretroviral activity and safety of the glucocorticoid receptor antagonist mifepristone in HIV-1-infected patients

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Abstract

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