ATN 109 Diagnoses Form [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 [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

来自诊断病例报告表[CRF 2]（Case Report Form）的数据
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周一次直接督导给药的维生素D与安慰剂的干预效果，干预周期共计48周。研究纳入的受试者为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）的联合抗逆转录病毒治疗超过180天。分别于基线、研究第24周及第48周，采用双能X线吸收法（Dual-energy X-ray Absorptiometry，DXA）对受试者的全身、脊柱及髋部骨密度（Bone Mineral Density，BMD）与骨矿含量（Bone Mineral Content，BMC）进行检测评估。
经行为途径感染HIV的16至24岁青年