Testosterone for HIV-Positive Men With Reduced Serum Testosterone Levels and Abdominal Fat
- Conditions
- HIV Infections
- Registration Number
- NCT00009555
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 86
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (27)
Northwestern University CRS
🇺🇸Chicago, Illinois, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
🇺🇸Honolulu, Hawaii, United States
University of Colorado Hospital CRS
🇺🇸Aurora, Colorado, United States
Queens Med. Ctr.
🇺🇸Honolulu, Hawaii, United States
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
IHV Baltimore Treatment CRS
🇺🇸Baltimore, Maryland, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
🇺🇸Indianapolis, Indiana, United States
Rush Univ. Med. Ctr. ACTG CRS
🇺🇸Chicago, Illinois, United States
Indiana Univ. School of Medicine, Wishard Memorial
🇺🇸Indianapolis, Indiana, United States
Methodist Hosp. of Indiana
🇺🇸Indianapolis, Indiana, United States
University of Minnesota, ACTU
🇺🇸Minneapolis, Minnesota, United States
St. Louis ConnectCare, Infectious Diseases Clinic
🇺🇸Saint Louis, Missouri, United States
Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
🇺🇸Omaha, Nebraska, United States
Washington U CRS
🇺🇸Saint Louis, Missouri, United States
NY Univ. HIV/AIDS CRS
🇺🇸New York, New York, United States
Puerto Rico-AIDS CRS
🇵🇷San Juan, Puerto Rico
Univ. of Cincinnati CRS
🇺🇸Cincinnati, Ohio, United States
Univ. of Pennsylvania Health System, Presbyterian Med. Ctr.
🇺🇸Philadelphia, Pennsylvania, United States
Pitt CRS
🇺🇸Pittsburgh, Pennsylvania, United States
Hosp. of the Univ. of Pennsylvania CRS
🇺🇸Philadelphia, Pennsylvania, United States