ATN 117 Eligibility Form [CRF 1] Dataset in Renal, Endocrine, and Bone Changes in Response to Treatment with Coformulated Emtricitabine-Tenofovir for Pre-Exposure HIV Prophylaxis (PrEP) in HIV Uninfected Young Men Who Have Sex with Men, a Sub-Study of ATN 110 and/or ATN 113

Data from Eligibility Form [CRF 1]
Study Description
An observational cohort sub-study of subjects enrolled in ATN 110 or ATN 113, and prescribed daily coformulated emtricitabine/tenofovir (FTC/TDF (Truvada®)) as part of ATN 110 or ATN 113, with the primary objective of measuring the magnitude of change in parathyroid hormone (PTH) from baseline to week 48. Renal, endocrine, and bone biochemistry changes and pathophysiology were explored as secondary objectives. Subjects were HIV uninfected YMSM, inclusive of transgender women, and were to be followed for at least 48 weeks; seronegative subjects in the Extension Phase of ATN 110 or ATN 113 were followed for an additional 48 weeks in the Extension Phase of ATN 117.
Young men who have sex with men, including transgender women, ages 15-22, and co-enrolled in ATN 110 or ATN 113

来自资格筛查表[病例报告表（Case Report Form, CRF）1]的数据
研究概况
本研究为一项观察性队列子研究，研究对象为纳入艾滋病临床试验组（AIDS Clinical Trials Group, ATN）110或ATN 113试验的受试者，且作为上述两项试验的常规给药方案组成部分，每日服用复方制剂恩曲他滨/替诺福韦（emtricitabine/tenofovir, FTC/TDF（Truvada®））。本研究的主要研究目标为测量甲状旁腺激素（parathyroid hormone, PTH）从基线至第48周的变化幅度。次要研究目标为探究肾脏、内分泌及骨骼生物化学指标的变化及其病理生理学机制。研究对象为人类免疫缺陷病毒（Human Immunodeficiency Virus, HIV）阴性的男男性行为青年（Young Men Who Have Sex with Men, YMSM），其中包括跨性别女性，所有受试者均需完成至少48周的随访；在ATN 110或ATN 113试验的扩展阶段入组的血清学阴性受试者，将在ATN 117试验的扩展阶段继续接受额外48周的随访。
本研究纳入的受试者为年龄15~22岁、入组ATN 110或ATN 113试验的男男性行为青年，其中包括跨性别女性。