Anti-HIV Activity and Safety of 3 Different Doses of Mifepristone in HIV Infected People
A Randomized, Placebo-Controlled, Phase I/II Trial of the Anti-HIV Activity and Safety of VGX-410 (Mifepristone) at Three Dose Levels in HIV-1 Infected Subjects
3 other identifiers
interventional
48
1 country
10
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 hiv-infections
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2004
CompletedFirst Posted
Study publicly available on registry
December 20, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedNovember 1, 2021
October 1, 2021
December 17, 2004
October 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in HIV-1 viral load from baseline to Days 14 and 28
Secondary Outcomes (7)
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
- +2 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- HIV-1 infected
- CD4 count of 350 cells/mm3 or more within 90 days prior to study entry
- HIV-1 viral load of 2000 copies/ml or more within 90 days prior to study entry
- Willing to use acceptable forms of contraception during the study and for 30 days after stopping study medication
- If currently taking precautionary concomitant medications, must be on stable doses for more than 8 weeks prior to study entry and have no plans to change medications or doses for the duration of the study
- Body weight at least 40 kg (88 lbs) within 90 days prior to study entry
You may not qualify if:
- Antiretroviral treatment (ART) within 16 weeks prior to study entry, or intend to start ART within 60 days after entry
- Adrenal disorders
- History of autoimmune endocrine disease in self or family
- History of active hepatitis B or C
- Current treatment for hepatitis B or C
- Moderate to severe liver disease
- Blood disorders or current anticoagulant therapy
- Prior pituitary tumor, surgery, radiation treatment, or pituitary failure
- Moderate to large goiters or thyroid nodules
- Diabetes mellitus
- Unusual uterine bleeding within 12 months prior to study entry
- Current hormonal contraception or intrauterine (IUD) use, including progesterone-containing vaginal rings
- Pregnancy within 90 days prior to study entry
- Breast-feeding
- Drugs that act as inhibitors or inducers of metabolism by cytochrome P450 3A4
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Harbor-UCLA Med. Ctr. CRS
Torrance, California, 90502-2052, United States
Georgetown University CRS (GU CRS)
Washington D.C., District of Columbia, 20007, United States
University of Minnesota, ACTU
Minneapolis, Minnesota, 55455-0392, United States
Washington U CRS
St Louis, Missouri, 63108-2138, United States
Unc Aids Crs
Chapel Hill, North Carolina, 27514, United States
The Ohio State Univ. AIDS CRS
Columbus, Ohio, 43210, United States
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, 19104, United States
Univ. of Pennsylvania Health System, Presbyterian Med. Ctr.
Philadelphia, Pennsylvania, 19104, United States
Pitt CRS
Pittsburgh, Pennsylvania, 15213-2582, United States
University of Washington AIDS CRS
Seattle, Washington, 98104, United States
Related Publications (3)
Schafer E, Wagner M, and Ayyavoo V. Antiviral Effects of Mifepristone and its Analogs on HIV-1 Vpr-Induced Virus Replication. 11th Conference on Retroviruses and Opportunistic Infections. February 2004.
BACKGROUNDAyyavoo V, Mahboubi A, Mahalingam S, Ramalingam R, Kudchodkar S, Williams WV, Green DR, Weiner DB. HIV-1 Vpr suppresses immune activation and apoptosis through regulation of nuclear factor kappa B. Nat Med. 1997 Oct;3(10):1117-23. doi: 10.1038/nm1097-1117.
PMID: 9334723BACKGROUNDPara MF, Schouten J, Rosenkranz SL, Yu S, Weiner D, Tebas P, White CJ, Reeds D, Lertora J, Patterson KB, Daar ES, Cavert W, Brizz B; ACTG A5200 Team of the ACTG. Phase I/II trial of the anti-HIV activity of mifepristone in HIV-infected subjects ACTG 5200. J Acquir Immune Defic Syndr. 2010 Apr 1;53(4):491-5. doi: 10.1097/QAI.0b013e3181d142cb.
PMID: 20130470RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Michael F. Para, MD
Ohio State University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2004
First Posted
December 20, 2004
Study Completion
August 1, 2005
Last Updated
November 1, 2021
Record last verified: 2021-10