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

HIV 阳性患者补充生理睾酮的试验（A5079）

• 批准号: 7379063
• 负责人: MICHAEL P DUBE
• 金额: $ 0.22万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7379063
• 关键词: TRIAL; PHYSIOLOGIC; TESTOSTERONE; SUPPLEMENTATION; HIV

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.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子弹和调查员（PI）可能已经从其他NIH来源获得了主要资金，因此可以在其他清晰的条目中代表。列出的机构适用于该中心，这不一定是调查员的机构。这是一项III期，前瞻性，多中心，随机，安慰剂对照，双盲研究，以检查内脏脂肪横截面区域的变化是否随着睾丸激素的替代而比安慰剂替代睾丸激素的变化大于HIV0阳性男性在稳定的有效抗逆转录病毒上的腹部男性疗法温和至中度降低血清睾丸激素水平。受试者将收到1）。 10克睾丸激素凝胶旨在在24小时或2个小时内向皮肤提供名义递送给皮肤。在研究的头24周中，匹配安慰剂凝胶。在第24周进行研究治疗的受试者将有资格再接受24周的开放标签睾丸激素凝胶。学习的受试者将在24周内再遵循24周，但不会接受开放标签的睾丸激素凝胶。在大多数情况下，这项研究的睾丸激素凝胶剂量预计将使受试者血清睾丸激素水平进入正常范围的中间（约600-800 ng/dl），在大多数情况下，为健康的年轻男性（约275-1200 ng/dl）定义。 86名受试者将被招募并接受研究药物最多48周。主要的研究目标是检验以下假设：在睾丸激素中，内脏脂肪横截面区域的变化将比睾丸激素替代的变化要大于腹部肥胖的HIV阳性男性中的安慰剂的变化，这些男性的腹部肥胖症有轻度至中度降低血清睾丸激素水平。