Clinical Trial: Anti-HIV Activity and Safety of 3 Different Doses of Mifepristone in HIV Infected People

This study is currently recruiting patients.

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

The purpose of this study is to determine the anti-HIV activity and safety of 3 different doses of mifepristone (VGX-410) in HIV infected people.

Condition Treatment or Intervention Phase
HIV Infections
 Drug: Mifepristone
Phase I
Phase II

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study

Official Title: 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

Further Study Details: 
Primary Outcomes: Changes in HIV-1 viral load from baseline to Days 14 and 28
Expected Total Enrollment:  48

Mifepristone (also known as VGX-410 and RU486) 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. 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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Antiretroviral treatment (ART) within 16 weeks prior to study entry, or intend to start ART within 60 days after entry
  • Adrenal disorders
  • History of active hepatitis B or C
  • Moderate to severe liver disease
  • Blood disorders or current anticoagulant therapy
  • Prior pituitary tumor, surgery, radiation treatment, or pituitary failure
  • Diabetes mellitus
  • Unusual uterine bleeding within 12 months prior to study entry
  • Current hormonal contraception or intrauterine (IUD) use, including progesterone-containing vaginal rings
  • 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.
  • Pregnancy within 90 days prior to study entry
  • Breast-feeding

Location and Contact Information


California
      Harbor General/UCLA, Torrance,  California,  90502-2052,  United States; Recruiting
Mario Guerrero, MD  310-222-3848    mguerrero@rei.edu 

District of Columbia
      Georgetown University Medical Center, Washington,  District of Columbia,  20007,  United States; Recruiting
Scott P Watson, RN, BS  202-687-7387    spw3@georgetown.edu 

Minnesota
      University of Minnesota, Minneapolis,  Minnesota,  55455-0392,  United States; Recruiting
Christine Fietzer, RN, BSN  612-625-1462    fietz002@umn.edu 

Missouri
      Washington University (St. Louis), St. Louis,  Missouri,  63108-2138,  United States; Recruiting
Michael Klebert, RN-C, MSN  314-454-0058    mklebert@im.wustl.edu 

North Carolina
      University of North Carolina, Chapel Hill,  North Carolina,  27514,  United States; Recruiting
Cheryl J. Marcus, RN, BSN  919-843-8761    cjm@med.unc.edu 

Ohio
      Ohio State University, Columbus,  Ohio,  43210,  United States; Recruiting
Todd L Lusch, BA  614-293-8112    lusch-1@medctr.osu.edu 

Pennsylvania
      University of Pittsburgh, Pittsburgh,  Pennsylvania,  15213-2582,  United States; Recruiting
Christine Tripoli, BSN, RN  412-647-0771    tripolica@msx.upmc.edu 

      University of Pennsylvania, Philadelphia, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting
Joseph Quinn, RN  215-349-8092    joseph.quinn@uphs.upenn.edu 

      Presbyterian Medical Center - Univ. of PA, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting
Joseph Quinn, RN  215-349-8092    joseph.quinn@uphs.upenn.edu 

Washington
      University of Washington (Seattle), Seattle,  Washington,  98104,  United States; Recruiting
Jeanne Conley, RN, BSN  206-731-8877    njc@u.washington.edu 

Study chairs or principal investigators

Michael F. Para, MD,  Study Chair,  Ohio State University   

More Information

Haga clic aquí para ver información sobre este ensayo clínico en español.

Publications

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.

Study ID Numbers:  ACTG A5200
Record last reviewed:  April 2005
Last Updated:  April 7, 2005
Record first received:  December 17, 2004
ClinicalTrials.gov Identifier:  NCT00099645
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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