Anti-HIV Activity and Safety of 3 Different Doses of Mifepristone in HIV Infected People
NCT ID: NCT00099645
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
48 participants
INTERVENTIONAL
2005-08-31
Brief Summary
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Hypothesis: Mifepristone will be generally safe (no serious adverse effects) and well tolerated.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Mifepristone
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* Systemic corticosteroids or hormonal agents within 90 days prior to study entry
* Any immunomodulator, HIV vaccine, or investigational therapy within 90 days prior to study entry
* Any vaccination within 30 days prior to study entry
* Systemic cytotoxic chemotherapy within 90 days prior to study entry
* History of allergy to mifepristone or the study formulations
* Current drug or alcohol abuse that, in the opinion of the investigator, may interfere with the study
* Any other conditions that may interfere with participant evaluation during the study
* Serious illness requiring systemic treatment or hospitalization. Patients who complete therapy or are clinically stable on therapy for at least 14 days prior to study entry are not excluded.
18 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Michael F. Para, MD
Role: STUDY_CHAIR
Ohio State University
Locations
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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
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
Countries
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References
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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.
Ayyavoo 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.
Para 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.
Other Identifiers
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10186
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG A5200
Identifier Type: -
Identifier Source: secondary_id
A5200
Identifier Type: -
Identifier Source: org_study_id