TRIAL OF PHYSIOLOGIC TESTOSTERONE SUPPLEMENTATION FOR HIV-POSITIVE(A5079)

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a phase III, prospective, multicenter, randomized, placebo-controlled, double-blind study to examine whether the change in visceral fat cross-sectional area is greater with testosterone replacement than with placebo in HIV0 positive men with abdominal on stable potent antiretroviral therapy who have mildly to moderately reduced serum testosterone levels. Subjects will receive either 1). 10g of testosterone gel designed to provide nominal delivery of 100mg testosterone to the skin over 24 hours or 2). Matching placebo gel for the first 24 weeks on the study. Subjects on study treatment at the week 24 will be eligible to receive open-label testosterone gel for an additional 24 weeks. Subjects on study but off drug at 24 weeks will be followed for an additional 24 weeks but will not receive open-label testosterone gel. This study dose of testosterone gel is anticipated to bring subjects serum testosterone levels into the middle (around 600-800 ng/dl) of the normal range defined for healthy young men (approximately 275-1200 ng/dl) in most cases. 86 subjects will be enrolled and receive study medication for a maximum of 48 weeks. The primary study objective is to test the hypothesis that the change in visceral fat cross-sectional area from baseline to 24 weeks will be greater with testosterone replacement than with placebo in HIV-positive men with abdominal obesity who have mildly to moderately reduced serum testosterone levels.