Testosterone for HIV-Positive Men With Reduced Serum Testosterone Levels and Abdominal Fat
|ClinicalTrials.gov Identifier: NCT00009555|
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : May 21, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Testosterone||Phase 4|
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 (Clinical Trial)|
|Enrollment :||86 participants|
|Official Title:||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|
|Actual Study Completion Date :||March 2006|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00009555
Show 27 Study Locations
|Study Chair:||Shalender Bhasin|
|Study Chair:||Cecilia Shikuma|