Testosterone for HIV-Positive Men With Reduced Serum Testosterone Levels and Abdominal Fat

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

A Prospective, Multicenter, Randomized, Placebo-Controlled Trial of Physiologic Testosterone Supplementation for HIV-Positive Men With Mildly to Moderately Reduced Serum Testosterone Levels and Abdominal Obesity

The purpose of this study is to see if treatment with testosterone will reduce abdominal fat in HIV-positive men.

Many HIV patients on antiretroviral therapy show an increase in abdominal fat. Studies have shown that treatment with testosterone may decrease abdominal fat. This study will determine if testosterone will reduce abdominal fat in HIV patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Reports suggest that many HIV-infected patients on antiretroviral therapy experience an increase in abdominal fat. The mechanisms of abdominal fat accumulation in HIV-infected patients are not known. Studies have shown: treatment with testosterone gel reduces total body fat in young, androgen-deficient men; testosterone replacement in middle-aged men with mid-segment obesity decreases visceral fat; and replacement doses of testosterone decrease fat mass and augment lean body mass in HIV-infected men with androgen deficiency. Therefore, there is a strong rationale for evaluating the effectiveness of testosterone replacement in HIV-infected men with visceral obesity and low testosterone levels.

Patients are stratified based on their viral load. Patients receive either testosterone gel or placebo applied to the skin once daily for 24 weeks. Patients remain on their current antiretroviral regimens, which are not supplied through the study. Patients who receive testosterone during the first 24 weeks are eligible to receive it for an additional 24 weeks. Patients on placebo are followed for an additional 24 weeks. Clinical and laboratory evaluations for visceral fat changes are performed throughout the study.

Study Type

Interventional

Enrollment

86

Phase

  • Phase 4

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

  • Puerto Rico
      • San Juan, Puerto Rico, 009365067
        • Puerto Rico-AIDS CRS
  • United States
    • California
      • Los Angeles, California, United States, 900331079
        • USC CRS
      • Los Angeles, California, United States, 90059
        • Charles R. Drew Univ. of Medicine and Science, Div. of Infectious Diseases
      • Palo Alto, California, United States, 943055107
        • Stanford CRS
      • San Diego, California, United States, 92103
        • Ucsd, Avrc Crs
      • San Francisco, California, United States, 94110
        • Ucsf Aids Crs
      • San Jose, California, United States
        • Santa Clara Valley Med. Ctr.
      • San Mateo, California, United States
        • San Mateo County AIDS Program
      • San Rafael, California, United States
        • Marin County Dept. of Health & Human Services, HIV/AIDS Program & Specialty Clinic
    • Colorado
      • Aurora, Colorado, United States, 80262
        • University of Colorado Hospital CRS
    • Hawaii
      • Honolulu, Hawaii, United States, 96816
        • Univ. of Hawaii at Manoa, Leahi Hosp.
      • Honolulu, Hawaii, United States, 96816
        • Queens Med. Ctr.
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University CRS
      • Chicago, Illinois, United States, 60612
        • Rush Univ. Med. Ctr. ACTG CRS
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Methodist Hosp. of Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana Univ. School of Medicine, Wishard Memorial
      • Indianapolis, Indiana, United States, 462025250
        • Indiana Univ. School of Medicine, Infectious Disease Research Clinic
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • IHV Baltimore Treatment CRS
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455-0392
        • University of Minnesota, ACTU
    • Missouri
      • Saint Louis, Missouri, United States, 63108
        • Washington U CRS
      • Saint Louis, Missouri, United States, 63108
        • St. Louis ConnectCare, Infectious Diseases Clinic
    • Nebraska
      • Omaha, Nebraska, United States
        • Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
    • New York
      • New York, New York, United States, 10016
        • NY Univ. HIV/AIDS CRS
    • Ohio
      • Cincinnati, Ohio, United States, 452670405
        • Univ. of Cincinnati CRS
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hosp. of the Univ. of Pennsylvania CRS
      • Philadelphia, Pennsylvania, United States
        • Univ. of Pennsylvania Health System, Presbyterian Med. Ctr.
      • Pittsburgh, Pennsylvania, United States, 15213
        • Pitt 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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are HIV-positive.
  • Have been taking anti-HIV medications for at least 12 weeks before study entry and plan to continue taking them for an additional 24 weeks.
  • Are male and between 18 and 70 years old.
  • Have a measurement of greater than 100 cm around the abdomen.
  • Can report an increase in abdominal size after taking antiretroviral drugs.
  • Have a viral load less than 10,000 copies/ml within 6 weeks prior to screening.
  • Have a serum total testosterone between 125 and 400 ng/dl. If serum total testosterone is greater than 400 ng/dl, bioavailable testosterone must be less than 115 ng/dl or free testosterone must be less than 50 pg/ml.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Take certain drugs, including testosterone derivatives, glucocorticoids, appetite stimulants, dronabinol, megestrol acetate, androstenediols, oxandrolone, or other anabolic agents such as dehydroepiandrosterone (DHEA) or growth hormone within 12 weeks prior to study entry.
  • Take hydroxyurea within 30 days of study entry.
  • Take drugs for diabetes.
  • Have diabetes.
  • Take granulocyte-macrophage colony-stimulating factor (GM-CSF). (Granulocyte colony-stimulating factor (G-CSF) is allowed.)
  • Take cytokines, cytokine inhibitors, or ketoconazole.
  • Take ritonavir with simvastatin or lovastatin.
  • Have an active opportunistic infection. Patients on treatment for at least 12 weeks will be allowed.
  • Have 5-7 loose stools per day or diarrhea for more than 1 week, within 6 weeks of study entry.
  • Have a blood pressure greater than 160 over 100.
  • Have certain heart problems.
  • Have a breast mass that has not been diagnosed.
  • Have active cancer.
  • Have had prostate cancer or certain other prostate problems.
  • Are allergic to any part of the testosterone gel.
  • Have a history of blood clots.
  • Have a history of sleep apnea.
  • Are receiving experimental treatment.
  • Are receiving experimental drugs in other studies and do not know if they are taking the drug or placebo.
  • Abuse drugs or alcohol in a way that would interfere with the study.
  • Are dieting or doing heavy exercising.
  • Have a viral load of 10,000 copies/ml or more at screening

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
  • Masking: Double

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: Cecilia Shikuma
  • Study Chair: Shalender Bhasin

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)

March 1, 2006

Study Registration Dates

First Submitted

February 1, 2001

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

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

  • A5079
  • 10175 (Registry Identifier: DAIDS ES)
  • ACTG A5079
  • AACTG A5079

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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