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

October 28, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment

48

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Torrance, California, United States, 90502-2052
        • Harbor-UCLA Med. Ctr. CRS
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University CRS (GU CRS)
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455-0392
        • University of Minnesota, ACTU
    • Missouri
      • Saint Louis, Missouri, United States, 63108-2138
        • Washington U CRS
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Unc Aids Crs
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State Univ. AIDS CRS
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hosp. of the Univ. of Pennsylvania CRS
      • Philadelphia, Pennsylvania, United States, 19104
        • Univ. of Pennsylvania Health System, Presbyterian Med. Ctr.
      • Pittsburgh, Pennsylvania, United States, 15213-2582
        • Pitt CRS
    • Washington
      • Seattle, Washington, United States, 98104
        • University of Washington AIDS CRS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Changes in HIV-1 viral load from baseline to Days 14 and 28

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

December 17, 2004

First Submitted That Met QC Criteria

December 17, 2004

First Posted (Estimate)

December 20, 2004

Study Record Updates

Last Update Posted (Actual)

November 1, 2021

Last Update Submitted That Met QC Criteria

October 28, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5200
  • 10186 (Other Identifier: CTEP)
  • ACTG A5200

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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