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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00009555 |
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 | Intervention | Phase |
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HIV Infections |
Drug: Testosterone |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind |
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 |
Estimated Enrollment: | 86 |
Study Completion Date: | March 2007 |
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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
Study Chair: | Shalender Bhasin | |
Study Chair: | Cecilia Shikuma |
Study ID Numbers: | ACTG A5079, AACTG 5079 |
Study First Received: | February 1, 2001 |
Last Updated: | December 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00009555 |
Health Authority: | United States: Food and Drug Administration |
Testosterone Anthropometry Obesity Abdomen |
Virus Diseases Obesity Testosterone Sexually Transmitted Diseases, Viral HIV Seropositivity HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Methyltestosterone Retroviridae Infections Immunologic Deficiency Syndromes Testosterone 17 beta-cypionate |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Antineoplastic Agents, Hormonal Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Infection Hormones Pharmacologic Actions Anabolic Agents Therapeutic Uses Lentivirus Infections Androgens |