ATN021:PREVALENCE OF MORPHOLOGIC AND METABOLIC ABNORMALITIES IN HIV INFECTED

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。设计：横断面调查，旨在评估艾滋病毒感染女性青年的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。本研究旨在评估感染HIV和未感染HIV的年轻女性在葡萄糖代谢、脂质、乳酸、身体成分和骨密度方面是否存在显著差异。此外，本研究将评估暴露于特定类别的抗逆转录病毒（ARV）药物是否以不同的方式与HIV感染者的代谢和形态异常相关。该研究包括一次性收集病史数据、实验室标本和身体评估。该研究将阐明需要进一步深入研究以蛋白酶抑制剂（PI）和非核苷类似物逆转录酶抑制剂（NNRT）为基础的治疗在年轻女性中的病理生理作用。样本量：一组50名HIV阴性受试者和四组50名HIV阳性受试者。人口：未感染艾滋病毒和感染艾滋病毒的女性，年龄12至24岁，Tanner期4或5期，未怀孕和过去12个月未怀孕。入组：符合条件的受试者将非随机入组，直到达到目标样本量。持续时间：一次入学前访问和一次学习期间访问。实际的研究访问可以在两(2)次单独访问中完成。数据收集：通过病史提取和/或访谈、体格评估、血液和尿液标本采集以及人体测量评估收集数据。医学图表提取和所有临床和实验室评估应在首次入职前研究访问后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、脂质、乳酸、体成分和骨密度异常的患病率；2)比较这些异常在未感染HIV的年轻女性、未接受抗逆转录病毒治疗、经历过NNRTI或蛋白酶抑制剂的HIV感染年轻女性以及经历过非蛋白酶、非NNRTI的年轻女性中的患病率；3)探讨该人群中药物和非药物因素与特定改变风险之间的关系。

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.