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Vitamin D Reabsorption in Adolescents and Young Adults With HIV Infection

2017年2月27日 更新者：University of North Carolina, Chapel Hill

Randomized, Placebo-controlled Trial of the Safety and Effectiveness of Vitamin D Supplement to Improve Tubular Reabsorption of Phosphate and Decrease Bone Turnover in Adolescents and Young Adults With HIV Infection Being Treated With Antiretroviral Therapy Containing Tenofovir Compared to Those Being Treated With Antiretroviral Therapy Not Containing Tenofovir

The purpose of this study is to test the effects of Vitamin D on renal phosphate and bone loss, which are common in HIV infected adolescents and young adults being treated with tenofovir.

研究概览

地位

完全的

条件

干预/治疗

详细说明

ATN 063 tests 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.

研究类型

介入性

注册 (实际的)

207

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 波多黎各
      • San Juan、波多黎各、00936
        • University of Puerto Rico
  • 美国
    • California
      • Los Angeles、California、美国、90027
        • Children's Hopsital of Los Angeles
      • San Francisco、California、美国、94143
        • University of California at San Francisco
    • District of Columbia
      • Washington、District of Columbia、美国、20010
        • Children's National Medical Center
    • Florida
      • Fort Lauderdale、Florida、美国、33316
        • Children's Diagnostic and Treatment Center
      • Miami、Florida、美国、33101
        • University of Miami
      • Tampa、Florida、美国、33606
        • University of South Florida
    • Illinois
      • Chicago、Illinois、美国、60614
        • Childrens Memorial Hospital
      • Chicago、Illinois、美国、60612
        • Stroger Hospital of Cook County
    • Louisiana
      • New Orleans、Louisiana、美国、70112
        • Tulane University
    • Maryland
      • Baltimore、Maryland、美国、21204
        • University of Maryland Medical School
    • New York
      • Bronx、New York、美国、10467
        • Montefiore Medical Center
      • New York、New York、美国、10128
        • Mount Sinai Hospital
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104
        • Children's Hospital of Philadelphia
    • Tennessee
      • Memphis、Tennessee、美国、38105
        • St. Jude Childrens Research Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 24年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Age 18 years and 0 days through 24 years and 364 days
  • HIV-1 infection as documented by any licensed ELISA test kit and confirmed by Western blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA at any time prior to study entry
  • Currently being treated with a stable FDA-approved ARV combination therapy, containing > 3 antiretrovirals, for > 28 days, according to HRSA guidelines. Treatment regimen will not be started or changed for the purposes of participation in this study. Subjects will be receiving therapy at the direction of their treating physician
  • Willingness to remain on the same ARV combination therapy for the 12-week duration of the study
  • Ability and willingness to participate in the study by providing written informed consent
  • Willingness to be randomized to receive either vitamin D or placebo

Exclusion Criteria:

  • Prior hypersensitivity to vitamin D
  • History of arteriosclerosis, renal stones, glomerulonephritis, nephrotic syndrome, or hypercalcemia
  • Lactation or current pregnancy
  • Active therapy for malignancy
  • Known presence of gastrointestinal disease that would interfere with drug administration or absorption
  • Serological evidence of Hepatitis B surface antigen (HBsAg)
  • Confirmed creatinine clearance < 90 ml/min (calculated GFR from serum creatinine using the MDRD formula)
  • Grade 3 or higher clinical toxicity

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：A: tenofovir/vitamin D
Vitamin D3 (cholecalciferol), 50,000 IU as a single capsule, will be administered orally to subjects in Group A (who are already taking Tenofovir) once every four weeks during study visits.
膳食补充剂：Vitamin D supplement
Vitamin D3 (cholecalciferol), 50,000 IU as a single capsule, will be administered orally to subjects in Groups A and C once every four weeks during study visits.
安慰剂比较：B: tenofovir/placebo
A placebo will be administered orally to subjects in Group B (who are already taking Tenofovir).
其他：Placebo
A placebo will be administered orally to subjects in Groups B and D once every four weeks during study visits.
实验性的：C: no tenofovir/vitamin D
Vitamin D3 (cholecalciferol), 50,000 IU as a single capsule, will be administered orally to subjects in Group C (who are not taking Tenofovir) once every four weeks during study visits.
膳食补充剂：Vitamin D supplement
Vitamin D3 (cholecalciferol), 50,000 IU as a single capsule, will be administered orally to subjects in Groups A and C once every four weeks during study visits.
安慰剂比较：D: no tenofovir/placebo
A placebo will be administered orally to subjects in Group D (who are not taking Tenofovir).
其他：Placebo
A placebo will be administered orally to subjects in Groups B and D once every four weeks during study visits.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
To compare the change in renal tubular reabsorption of phosphate and markers of bone turnover.
大体时间：Baseline, Week 4, Week 12
Baseline, Week 4, Week 12
To measure the safety of 50,000 IU dose of vitamin D3
大体时间：Baseline, Week 4, and Week 8
Baseline, Week 4, and Week 8

次要结果测量

结果测量
大体时间
To measure the relationship of vitamin D plasma concentrations to renal tubular reabsorption of phosphate and markers of bone turnover
大体时间：Baseline, Week 4, and Week 12
Baseline, Week 4, and Week 12
To measure the relationship of tenofovir exposure to renal tubular reabsorption of phosphate and markers of bone turnover
大体时间：Baseline, Week 4, and Week 12
Baseline, Week 4, and Week 12
To measure the change in tenofovir exposure and creatinine clearance
大体时间：Baseline, Week 4, and Week 12
Baseline, Week 4, and Week 12

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of North Carolina, Chapel Hill

合作者

National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)

调查人员

  • 学习椅：Peter L Havens, M.S., M.D.、Medical College of Wisconsin

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2007年12月1日

初级完成 (实际的)

2010年1月1日

研究完成 (实际的)

2010年1月1日

研究注册日期

首次提交

2007年6月21日

首先提交符合 QC 标准的

2007年6月21日

首次发布 (估计)

2007年6月22日

研究记录更新

最后更新发布 (实际的)

2017年2月28日

上次提交的符合 QC 标准的更新

2017年2月27日

最后验证

2016年2月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • ATN 063

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

艾滋病毒感染的临床试验

Vitamin D supplement的临床试验

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赞助者和合作者

医疗条件

药物干预

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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