ATN 109 Subject Screening Log [CRF FSCR] 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 Subject Screening Log [CRF FSCR]
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

受试者筛查日志数据 [CRF FSCR]

研究概况
本研究为一项随机双盲安慰剂对照试验，旨在对比每4周一次直接督导下维生素D给药与安慰剂的干预效果，干预周期共48周。受试者为16至24岁的HIV感染青年，其病毒载量低于200拷贝/mL，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超过180天。在基线、研究第24周及第48周，采用双能X线吸收测定法（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）与骨矿物质含量（Bone Mineral Content, BMC）进行检测。

经行为途径感染HIV的16至24岁青年