ATN 021b Off Study Form [CRF 98] Dataset in Prevalence of Morphologic and Metabolic Abnormalities in HIV Infected and Uninfected Young Men

Data from Off Study Form [CRF 98]
Study Description
A multi-center, cross-sectional study of HIV infected and uninfected males, ages 12 to 24, that evaluated the prevalence and severity of morphologic and metabolic abnormalities in HIV-infected young men and assessed the drug and non-drug factors related to these abnormalities. Differences in glucose metabolism, lipids, lactate, body composition, and bone density between HIV infected and uninfected young men were assessed to understand the pathophysiological effects of protease inhibitor (PI)-based and non-nucleoside reverse transcriptase inhibitor (NNRTI)-based therapies in young men. One study visit conducted over 1 or more days included survey questionnaires, DEXA scanning, collection of blood and urine specimens, anthropometric measurements, and blood tests examining glucose and lipid metabolism and levels of C-Reactive protein and lactate. Biospecimens are available. HIV infected and uninfected males, ages 12 to 24, of Tanner Stage 4 or 5

数据来自病例报告表[CRF 98]
研究概况
本研究为一项多中心横断面研究，纳入年龄12至24岁的HIV感染者与未感染男性群体，旨在评估HIV感染青年男性的形态学与代谢异常的患病率及严重程度，并分析与这类异常相关的药物及非药物影响因素。研究同时对比了HIV感染者与未感染青年男性在葡萄糖代谢、血脂、乳酸、身体成分及骨密度方面的差异，以明确基于蛋白酶抑制剂(PI)与非核苷类逆转录酶抑制剂(NNRTI)的治疗方案对青年男性的病理生理影响。单次研究随访可历时1天及以上，涵盖问卷调查、双能X线吸收测定法(DEXA)扫描、血液与尿液标本采集、人体测量学指标检测，以及针对葡萄糖与脂质代谢、C反应蛋白及乳酸水平的血液检验项目。现有生物标本可供获取。本研究纳入对象为坦纳分期4期或5期、年龄12至24岁的HIV感染与未感染男性群体。