USE OF NUTROPIN DEPOT IN HIV-INFECTED ADULT MALES

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。替代生长激素（GH）在艾滋病毒感染的成年人已被证明增加瘦组织质量和临床统计。以前的研究使用每日皮下注射进行长达6个月。本研究的目的是比较生长激素储备和每日生长激素的代谢影响，并研究生长激素对hiv感染成年男性的短期和长期（12个月）代谢影响。(这个小规模的试点研究将只包括男性，以尽可能提供受试者群体的一致性。在对试点数据进行分析后，将计划进行一项包括女性在内的更大规模的研究，以提交拨款申请。)研究人群将包括10名有脂肪萎缩的患者和10名无脂肪萎缩的患者，这些患者平均分布在每日皮下注射Nutropin AQ或Nutropin Depot。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：肝糖生成、糖异生、蛋白质转换、骨矿物质转换和tnf - α水平。这项研究将为生长激素对hiv感染成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.