ATN021:PREVALENCE OF MORPHOLOGIC AND METABOLIC ABNORMALITIES IN HIV INFECTED

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。设计：横断面调查，旨在评估感染HIV的女性青年中形态和代谢异常的患病率和严重程度，并评估与这些异常相关的药物和非药物因素。这项研究旨在评估感染HIV的年轻女性与未感染HIV的年轻女性在糖代谢、血脂、乳酸、身体成分和骨密度方面是否存在显著差异。此外，这项研究将评估接触特定类别的抗逆转录病毒(ARV)药物是否以不同方式与HIV感染者的代谢和形态异常有关。这项研究包括一次性收集病史数据、实验室标本和身体评估。这项研究将阐明进一步深入研究的必要性，以了解以蛋白酶抑制剂(PI)和非核苷类似物逆转录酶抑制剂(NNRT)为基础的治疗对年轻女性的病理生理影响。样本大小：一组为50名HIV阴性受试者，四组为50名HIV阳性受试者。人群：未感染和感染HIV的女性，年龄12-24岁，Tanner 4或5期，过去12个月内未怀孕和未怀孕。登记：符合条件的受试者将以非随机方式登记参加研究，直到达到目标样本量。持续时间：一次入境前参观和一次实地考察。实际的实地考察访问可分两(2)次完成。数据收集：将通过病史摘要和/或面谈、身体评估、血液和尿液样本采集以及人体测量评估来收集数据。病历摘要和所有临床和实验室评估应在首次入境前研究访问的30天内完成。目的：1)确定HIV感染和未感染的年轻女性中糖代谢、血脂、乳酸、体成分和骨密度异常的发生率；2)比较HIV未感染和HIV感染的年轻女性中这些异常的发生率；2)比较HIV感染的年轻女性中这些异常的发生率，这些异常在HIV感染的年轻女性中是幼稚的，有过NNRTI经历或有过蛋白酶抑制剂经历的女性，以及没有经历过非NNRTI经历的；3)研究药物和非药物因素与这一人群中特定改变的风险的关系。

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. Design: Cross-sectional survey designed to evaluate the prevalence and severity of morphologic and metabolic abnormalities in HIV infected female youth and to assess the drug and non-drug factors related to these abnormalities. This study is designed to assess whether there exists significant differences in glucose metabolism, lipids, lactate, body composition and bone density between HIV infected and uninfected young women. Furthermore, this study will evaluate whether exposure to specific classes of antiretroviral (ARV) medications is associated with the metabolic and morphologic abnormalities among the HIV infected individuals in different ways. The study involves a one-time collection of medical history data, laboratory specimens, and physical assessments. This study will elucidate the need for further in-depth study to understand the pathophysiological effects of protease inhibitor (PI) and non-nucleoside analogue reverse transcriptase inhibitor (NNRT)-based therapies in young females. Sample size: One group of 50 HIV negative subjects and four groups of 50 HIV positive subjects. Population: HIV uninfected and infected females, aged 12 through 24 years, of Tanner Stage 4 or 5, non-pregnant and no pregnancy in past l2 months. Enrollment: Eligible subjects will be enrolled into the study non-randomly until target sample size is reached. Duration: One pre-entry visit and one on-study visit. The actual on-study visit may be completed over two (2) separate visits. Data Collection: Data will be collected through medical history abstraction and/or interview, physical assessments, blood and urine specimen collection, and anthropometric evaluation. Medical chart abstraction and all clinical and laboratory evaluations are to be completed within 30 days of initial pre-entry study visit. Objectives: 1)To determine the prevalence of abnormalities in glucose metabolism, lipids, lactate, body composition and bone density in HIV infected and HIV uninfected young women; 2) To compare the prevalence of these abnormalities among HIV uninfected young women, HIV infected young women who are antiretroviral naive,NNRTI experienced or protease inhibitor experienced, and non-protease, non-NNRTI experienced; 3) To examine the relationship between drug and non-drug factors and risk of specific alterations in this population.