ATN021:PREVALENCE OF MORPHOLOGIC AND METABOLIC ABNORMALITIES IN HIV INFECTED

ATN021：HIV 感染者形态和代谢异常的患病率

• 批准号: 7376277
• 负责人: Sue Ellen Abdalian
• 金额: $ 0.4万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 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/7376277
• 关键词: ATN021; PREVALENCE; MORPHOLOGIC; METABOLIC; ABNORMALITIES

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.

该子项目是利用 NIH/NCRR 资助的中心拨款提供的资源的众多研究子项目之一。子项目和研究者 (PI) 可能已从另一个 NIH 来源获得主要资金，因此可以在其他 CRISP 条目中得到体现。列出的机构是中心的机构，不一定是研究者的机构。设计：横断面调查旨在评估感染艾滋病毒的女性青少年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艾滋病毒和未感染艾滋病毒的年轻女性在葡萄糖代谢、血脂、乳酸、身体成分和骨密度方面是否存在显着差异。此外，本研究还将评估接触特定类别的抗逆转录病毒（ARV）药物是否与 HIV 感染者的代谢和形态异常以不同方式相关。该研究涉及一次性收集病史数据、实验室标本和身体评估。这项研究将阐明需要进一步深入研究，以了解基于蛋白酶抑制剂（PI）和非核苷类似物逆转录酶抑制剂（NNRT）的疗法对年轻女性的病理生理学影响。 样本量：一组 50 名 HIV 阴性受试者，四组 50 名 HIV 阳性受试者。 人群：未感染和感染 HIV 的女性，年龄 12 至 24 岁，处于 Tanner 4 或 5 期，未怀孕且过去 12 个月内未怀孕。入组：符合条件的受试者将非随机入组到研究中，直到达到目标样本量。 持续时间： 1 次入学前访问和 1 次研究中访问。实际的研究访问可以通过两 (2) 次单独的访问来完成。 数据收集：数据将通过病史摘要和/或访谈、身体评估、血液和尿液样本采集以及人体测量评估来收集。 医学图表摘要以及所有临床和实验室评估应在初次入组前研究访视后 30 天内完成。 目的： 1) 确定感染艾滋病毒和未感染艾滋病毒的年轻女性糖代谢、血脂、乳酸、身体成分和骨密度异常的患病率； 2) 比较未感染 HIV 的年轻女性、未接受过抗逆转录病毒治疗、经历过 NNRTI 或经历过蛋白酶抑制剂以及未经历过蛋白酶、非 NNRTI 的 HIV 感染年轻女性中这些异常的患病率； 3) 检查药物和非药物因素之间的关系以及该人群特定变化的风险。