ATN 109 Adverse Event Explanation Form [CRF 95] 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 Adverse Event Explanation Form [CRF 95]
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

来自不良事件解释表[CRF 95]的数据
研究概况
本研究为一项随机双盲安慰剂对照试验，每4周给予直接督导下的维生素D或安慰剂，干预时长共计48周。受试者为年龄16~24岁的HIV感染青年，其病毒载量<200拷贝/毫升，且已接受含TDF的联合抗反转录病毒治疗超过180天。分别于基线、研究第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、脊柱及髋部的骨密度（Bone Mineral Density, BMD）与骨矿物质含量（Bone Mineral Content, BMC）。

经行为传播感染HIV的青年，年龄16至24岁。