USE OF NUTROPIN DEPOT IN HIV-INFECTED ADULT MALES

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。在感染艾滋病毒的成年人中替代生长激素(GH)已被证明可以增加瘦组织质量和临床统计数据。以前的研究是使用每日皮下注射进行的，最长可达六个月。本研究的目的是比较生长激素库与每日生长激素的代谢效应，并研究生长激素在感染HIV的成年男性中的短期和长期(12个月)代谢效应。(这项小规模的试验性研究将只包括男性，以提供尽可能多的受试者群体的一致性。在分析了试点数据后，计划在拨款申请中进行一项更大规模的研究，以纳入女性。)研究人群将包括10名有脂肪萎缩的患者和10名没有脂肪萎缩的患者，这些患者平均每天服用Nutroin AQ或Nutroin Depot皮下注射。主要终点将是通过DXA扫描测量的瘦组织和身体成分的变化。其他研究终点包括：肝脏葡萄糖生成、糖异生、蛋白质周转、骨矿转换率和肿瘤坏死因子-α水平。这项研究将为生长激素对感染艾滋病毒的成年人的代谢影响提供新的长期信息。

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. Replacement of growth hormone (GH) in HIV infected adults has been proven to increase lean tissue mass and clinical stats. Previous studies have been conducted using daily subcutaneous injections for up to six months. The purpose of this study is to compare the metabolic effects of GH depot to daily GH, and to study short-term and long-term (12 months) metabolic effects of GH in the HIV-infected adult males. (Males only will be included in this small pilot study to provide as much uniformity in the subject population as possible. After pilot data is analyzed, a larger study to include women is planned for a grant submission.) The study population will include 10 patients with and 10 patients without lipoatrophy evenly distributed on either subcutaneous daily Nutropin AQ or Nutropin Depot. The major endpoint will be change in lean tissue and body composition as measured by DXA scan. The other study endpoints include: hepatic glucose production, gluconeogenesis, protein turnover, bone mineral turnover and TNF-alpha levels. This study will provide new long-term information on the metabolic effects of GH in HIV-infected adults.