Testosterone for HIV-Positive Men With Reduced Serum Testosterone Levels and Abdominal Fat
NCT ID: NCT00009555
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
86 participants
INTERVENTIONAL
2006-03-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
DOUBLE
Interventions
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Testosterone
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
MALE
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Shalender Bhasin
Role: STUDY_CHAIR
Cecilia Shikuma
Role: STUDY_CHAIR
Locations
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USC CRS
Los Angeles, California, United States
Charles R. Drew Univ. of Medicine and Science, Div. of Infectious Diseases
Los Angeles, California, United States
Stanford CRS
Palo Alto, California, United States
Ucsd, Avrc Crs
San Diego, California, United States
Ucsf Aids Crs
San Francisco, California, 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, United States
Queens Med. Ctr.
Honolulu, Hawaii, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, United States
Northwestern University CRS
Chicago, Illinois, United States
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, United States
Indiana Univ. School of Medicine, Wishard Memorial
Indianapolis, Indiana, United States
Methodist Hosp. of Indiana
Indianapolis, Indiana, United States
IHV Baltimore Treatment CRS
Baltimore, Maryland, United States
University of Minnesota, ACTU
Minneapolis, Minnesota, United States
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri, United States
Washington U CRS
St Louis, Missouri, United States
Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
Omaha, Nebraska, United States
NY Univ. HIV/AIDS CRS
New York, New York, United States
Univ. of Cincinnati CRS
Cincinnati, Ohio, United States
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, United States
Univ. of Pennsylvania Health System, Presbyterian Med. Ctr.
Philadelphia, Pennsylvania, United States
Pitt CRS
Pittsburgh, Pennsylvania, United States
Puerto Rico-AIDS CRS
San Juan, , Puerto Rico
Countries
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Other Identifiers
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10175
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG A5079
Identifier Type: -
Identifier Source: secondary_id
AACTG A5079
Identifier Type: -
Identifier Source: secondary_id
A5079
Identifier Type: -
Identifier Source: org_study_id