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

Completed · Phase 4

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00009555

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

86

Expected to finish

2006-03-01

Last updated by the study team

2021-11-01

Who can join

Age: 18 and older, up to 70. Sex: male. Healthy volunteers: not accepted.

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.
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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