ATN 063_CRF 7 Signs and Symptoms 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 PE and Signs and Symptoms Form: Signs and Symptoms [CRF 7]
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

来自体格检查（Physical Examination，PE）与症状体征记录表：症状体征 [病例报告表（Case Report Form，CRF）7]
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：在接受替诺福韦作为抗反转录病毒（Antiretroviral，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中，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、降低血浆甲状旁腺激素（Parathyroid Hormone，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（Bone Alkaline Phosphatase，BAP）的水平。
本研究为为期12周的随机安慰剂对照试验，共设置4个试验组：替诺福韦联合维生素D组、替诺福韦单药组、维生素D单药组及空白对照组（既未接受替诺福韦也未接受维生素D）。
研究对象为18至24岁的HIV-1感染男性及女性受试者。