ATN 109 Diagnoses Form: AIDS-Defining Diagnoses [CRF 2] Dataset in Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Effectiveness of Vitamin D3 Supplement to Increase Bone Mineral Density and Decrease Tenofovir-Induced Hyperparathyroidism in HIV Positive Youth Treated with ART Containing Tenofovir

Data from Diagnoses Form: AIDS-Defining Diagnoses [CRF 2]
Study Description
A randomized, double-blind, placebo-controlled trial of directly observed vitamin D versus placebo every 4 weeks for 48 weeks. Participants included HIV-infected youth ages 16-24 with viral load <200 copies/mL, and taking TDF-containing combination antiretroviral therapy for >180 days. Whole-body, spine, and hip BMD and BMC were assessed using DXA at baseline and at study weeks 24 and 48.

Behaviorally-acquired HIV-positive youth, aged 16 to 24

诊断表单数据：艾滋病确诊诊断相关数据（Case Report Form, CRF 2）
研究概况
本研究为一项随机双盲安慰剂对照试验，对比每4周给药一次、持续48周的直接督导下维生素D干预与安慰剂的疗效。受试者纳入标准为16至24岁的HIV感染青年，其病毒载量低于200拷贝/毫升，且已接受含替诺福韦酯（Tenofovir Disoproxil Fumarate, TDF）的联合抗反转录病毒治疗时长超过180天。研究人员于基线、试验第24周及第48周时，采用双能X线吸收测定法（Dual-energy X-ray Absorptiometry, DXA）检测受试者的全身、脊柱及髋部骨密度（Bone Mineral Density, BMD）与骨矿物质含量（Bone Mineral Content, BMC）。
经行为途径感染HIV的16至24岁青年