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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00099645
First received: December 17, 2004
Last updated: May 17, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Mifepristone
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Changes in HIV-1 viral load from baseline to Days 14 and 28

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 48
Study Completion Date: August 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00099645

Locations
United States, California
Harbor-UCLA Med. Ctr. CRS
Torrance, California, United States, 90502-2052
United States, District of Columbia
Georgetown University CRS (GU CRS)
Washington, District of Columbia, United States, 20007
United States, Minnesota
University of Minnesota, ACTU
Minneapolis, Minnesota, United States, 55455-0392
United States, Missouri
Washington U CRS
St. Louis, Missouri, United States, 63108-2138
United States, North Carolina
Unc Aids Crs
Chapel Hill, North Carolina, United States, 27514
United States, Ohio
The Ohio State Univ. AIDS CRS
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, United States, 19104
Univ. of Pennsylvania Health System, Presbyterian Med. Ctr.
Philadelphia, Pennsylvania, United States, 19104
Pitt CRS
Pittsburgh, Pennsylvania, United States, 15213-2582
United States, Washington
University of Washington AIDS CRS
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Investigators
Study Chair: Michael F. Para, MD Ohio State University
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00099645     History of Changes
Other Study ID Numbers: A5200, 10186, ACTG A5200
Study First Received: December 17, 2004
Last Updated: May 17, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Mifepristone
Mifeprex
RU486
VGX-410
Abortion Pill
Investigational Drug

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Mifepristone
Abortifacient Agents
Abortifacient Agents, Steroidal
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Contraceptives, Postcoital
Contraceptives, Postcoital, Synthetic
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014