ATN 063 Westrax Randomization Dataset in Randomized, Placebo-Controlled Trial of Safety and Effectiveness of Vitamin D Supplement to Improve Tubular Reabsorption of Phosphate and Decrease Bone Turnover in HIV-infected Adolescents and Young Adults Treated with ART Containing Tenofovir

Data from Westrax Randomization Sheet [CRF RAND]
Study Description
This study was a randomized, double-blind, placebo-controlled prospective study. The study tested the hypothesis that in a population of adolescents and young adults with HIV infection who are being treated with tenofovir as part of an antiretroviral (ARV) combination regimen, vitamin D supplementation will decrease renal phosphate loss, increase plasma phosphate, decrease plasma PTH, and improve markers of bone turnover, including a decrease in plasma N-telopeptide and BAP. A randomized, placebo-controlled trial was conducted over 12 weeks, with four arms: those who received tenofovir and vitamin D, those who received tenofovir and no vitamin D, those who received vitamin D and no tenofovir, and those who received neither tenofovir nor vitamin D.
HIV-1 infected males and females, ages 18 to 24

数据源自Westrax随机化记录表[CRF RAND]
研究概况
本研究为一项随机、双盲、安慰剂对照的前瞻性研究，旨在验证下述假说：对于正在接受以替诺福韦（tenofovir）作为抗逆转录病毒（ARV）联合治疗方案组成部分的HIV感染青少年及年轻成人人群，补充维生素D可减少肾脏磷酸盐丢失、升高血浆磷酸盐水平、降低血浆甲状旁腺素（PTH）水平，并改善骨转换标志物水平，具体包括降低血浆N端肽（N-telopeptide）与骨碱性磷酸酶（BAP）水平。
本随机安慰剂对照试验周期为12周，共设置四组干预方案：同时接受替诺福韦与维生素D组、仅接受替诺福韦未补充维生素D组、仅补充维生素D未使用替诺福韦组，以及既未使用替诺福韦也未补充维生素D组。
研究对象为18至24岁的HIV-1感染男性及女性受试者。