Testosterone for HIV-Positive Men With Reduced Serum Testosterone Levels and Abdominal Fat
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
4 other identifiers
interventional
86
2 countries
27
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 hiv-infections
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2001
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedNovember 1, 2021
October 1, 2021
February 1, 2001
October 28, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
USC CRS
Los Angeles, California, 900331079, United States
Charles R. Drew Univ. of Medicine and Science, Div. of Infectious Diseases
Los Angeles, California, 90059, United States
Stanford CRS
Palo Alto, California, 943055107, United States
Ucsd, Avrc Crs
San Diego, California, 92103, United States
Ucsf Aids Crs
San Francisco, California, 94110, United States
Santa Clara Valley Med. Ctr.
San Jose, California, United States
San Mateo County AIDS Program
San Mateo, California, United States
Marin County Dept. of Health & Human Services, HIV/AIDS Program & Specialty Clinic
San Rafael, California, United States
University of Colorado Hospital CRS
Aurora, Colorado, 80262, United States
Queens Med. Ctr.
Honolulu, Hawaii, 96816, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, 96816, United States
Northwestern University CRS
Chicago, Illinois, 60611, United States
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, 60612, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, 462025250, United States
Indiana Univ. School of Medicine, Wishard Memorial
Indianapolis, Indiana, 46202, United States
Methodist Hosp. of Indiana
Indianapolis, Indiana, 46202, United States
IHV Baltimore Treatment CRS
Baltimore, Maryland, 21201, United States
University of Minnesota, ACTU
Minneapolis, Minnesota, 55455-0392, United States
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri, 63108, United States
Washington U CRS
St Louis, Missouri, 63108, United States
Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
Omaha, Nebraska, United States
NY Univ. HIV/AIDS CRS
New York, New York, 10016, United States
Univ. of Cincinnati CRS
Cincinnati, Ohio, 452670405, United States
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, 19104, United States
Univ. of Pennsylvania Health System, Presbyterian Med. Ctr.
Philadelphia, Pennsylvania, United States
Pitt CRS
Pittsburgh, Pennsylvania, 15213, United States
Puerto Rico-AIDS CRS
San Juan, 009365067, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Shalender Bhasin
- STUDY CHAIR
Cecilia Shikuma