Para M.F.,Ohio State University |
Schouten J.,University of Washington |
Rosenkranz S.L.,Harvard University |
Yu S.,Harvard University |
And 9 more authors.
Journal of Acquired Immune Deficiency Syndromes | Year: 2010
BACKGROUND: 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. METHODS: 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 ≥350 cells per cubic millimeter who had no recent antiretroviral therapy. RESULTS: 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 on day 28 in the mifepristone arms, but the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) did not change. Three subjects (7.3%) receiving mifepristone developed a grade 2 rash. CONCLUSIONS: Mifepristone at doses of 75-225 mg daily was safe and well-tolerated, but did not show significant anti-HIV activity. Copyright © 2010 by Lippincott Williams & Wilkins.
VGX Pharmaceuticals Inc. | Date: 2008-09-08
Pharmaceutical compositions, namely, a nucleotide sequence that encodes an antigen, such as a DNA plasmid having an antigen encoding sequence like DNA, for the prevention or treatment of acquired immunodeficiency syndrome (AIDS).
Inovio Pharmaceuticals, Inc. and VGX Pharmaceuticals Inc. | Date: 2011-07-26
Pharmaceutical compositions, namely, a nucleotide sequence that encodes an antigen, such as a DNA plasmid having an antigen encoding sequence and like DNA, for the prevention or treatment of acquired immunodeficiency syndrome (AIDS).
Inovio Pharmaceuticals, Inc. and VGX Pharmaceuticals Inc. | Date: 2009-12-15
Vgx Pharmaceuticals Llc | Date: 2010-04-16
Devices and methods for delivering an electropermeabilizing pulse of electric energy to a tissue surface to enable delivery into cells in the tissue therapeutic substances. The device incorporates a source capable of generating a sufficient voltage potential to deliver a spark across a gap and delivers same to the tissue surface.