The purpose of this study is to determine the anti-HIV activity and safety of 3 different doses of mifepristone (also known as VGX-410 and RU486) in HIV infected people. Hypothesis: Mifepristone will be generally safe (no serious adverse effects) and well tolerated.
Mifepristone is a potent anti-glucocorticoid compound that effectively inhibits replication of both laboratory and clinical HIV isolates in vitro. This study will evaluate the anti-HIV activity and safety of 3 different doses of mifepristone in HIV infected people. This study will last approximately 2 months. Participants will be randomly assigned to one of 4 study arms, and will receive either mifepristone or placebo daily for 28 days. Arm A participants will receive one of three doses of placebo; Arm B participants will receive 75 mg mifepristone; Arm C participants will receive 150 mg mifepristone; and Arm D participants will receive 225 mg mifepristone. A thorough neck and thyroid examination will be performed within 30 days prior to study entry. Blood collection and vital signs measurement will occur at study entry and Days 3, 7, 14, 21, 28, and 56. Urine collection and pill counts will also be done at some study visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
Harbor-UCLA Med. Ctr. CRS
Torrance, California, United States
Georgetown University CRS (GU CRS)
Washington D.C., District of Columbia, United States
University of Minnesota, ACTU
Minneapolis, Minnesota, United States
Changes in HIV-1 viral load from baseline to Days 14 and 28
Within 28 days on study, occurrence of toxicity, rash, and symptoms of adrenal insufficiency, including fatigue, nausea, anorexia, vomiting, and dizziness
changes from baseline viral load on Days 7, 14, 21, 28, and 56
pre-dose concentrations of mifepristone on Days 14 and 28 and serum level of alpha-1 acidic glycoprotein (AAG) at Day 0
percentage and counts of CD4 and CD8 cells at baseline and on Days 14, 28, and 56
Vpr amino acid sequences on Days 0, 14, 28, and 56
comparison of the magnitude and diversity of effector T cell response to HIV antigens at Days 0, 28, and 56
change in fasting concentrations of plasma insulin, free fatty acids, high-density lipoprotein (HDL) cholesterol and triglycerides, and in insulin sensitivity between Days 0 and 28
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Washington U CRS
St Louis, Missouri, United States
Unc Aids Crs
Chapel Hill, North Carolina, United States
The Ohio State Univ. AIDS CRS
Columbus, Ohio, United States
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, United States
Univ. of Pennsylvania Health System, Presbyterian Med. Ctr.
Philadelphia, Pennsylvania, United States
Pitt CRS
Pittsburgh, Pennsylvania, United States
University of Washington AIDS CRS
Seattle, Washington, United States