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

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。这是一项III期、前瞻性、多中心、随机、安慰剂对照、双盲研究，旨在研究在接受稳定有效抗逆转录病毒治疗且血清睾酮水平轻度至中度降低的hiv阳性腹部患者中，睾酮替代是否比安慰剂的内脏脂肪横截面积变化更大。受试者将接受1)10g睾酮凝胶，用于在24小时内向皮肤提供100mg睾酮；或2)。在研究的前24周使用安慰剂凝胶。在第24周接受研究治疗的受试者将有资格再接受开放标签睾酮凝胶治疗24周。正在接受研究但在24周停药的受试者将再随访24周，但不接受开放标签睾酮凝胶。在大多数情况下，该研究剂量的睾酮凝胶预计将使受试者的血清睾酮水平达到健康年轻男性正常范围（约275-1200 ng/dl）的中间（约600-800 ng/dl）。86名受试者将被纳入研究，并接受最多48周的研究药物。本研究的主要目的是验证一种假设，即在血清睾酮水平轻度至中度降低的hiv阳性腹部肥胖男性中，睾酮替代比安慰剂从基线到24周的内脏脂肪横截面积变化更大。

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.