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临床试验/NCT01343225
NCT01343225Unknown4 期

Pilot Study of the Effect of a Non-tenofovir, Non-efavirenz-based HIV Regimen on Bone Density and Vitamin D Levels in African-American Patients With HIV Infection

East Carolina University0 个研究点入组 40 人开始时间: 2011年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
40
主要终点
Vitamin D levels and bone density

研究概览

简要总结

  1. Objectives

  2. To determine the vitamin D status of African-American HIV patients who are HIV-treatment naïve.

  3. To compare the effects of an efavirenz-containing regimen to a protease inhibitor regimen on 25-hydroxyvitamin D and 1,25 dihydroxyvitamin D3 levels.

  4. To compare the effect on bone density of a tenofovir- and efavirenz-containing regimen to a regimen that does not contain these drugs.

  5. To compare the efficacy of an alternative regimen (raltegravir, darunavir, ritonavir) to a standard once-daily regimen (tenofovir-emtricitabine-efavirenz).

Hypothesis

The investigators hypothesize that patients receiving efavirenz will be more likely to have lower 25-hydroxyvitamin D and 1,25 dihydroxyvitamin D3levels based on the fact that efavirenz is an inducer of CYP3A4 and CYP24 enzymes that degrade 25-hydroxyvitamin D and 1,25 dihydroxyvitamin D3, respectively, to inactive metabolites. The investigators speculate that patients on a tenofovir-containing regimen will be more likely to have progression of bone density loss compared to those in the non-tenofovir-containing regimen.

研究设计

研究类型
干预性
分配方式
随机
干预模型
平行分组
主要目的
基础科学
盲法
开放(无盲法)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • age between 18 and 50 years old
  • HIV infection and HIV RNA > 4000 copies/ml of plasma

排除标准

  • known risks for osteoporosis, including low body mass index (BMI < 20)
  • chronic alcohol use
  • chronic steroid use
  • use of phenytoin or phenobarbital
  • chronic renal insufficiency (calculated glomerular filtration rate < 50 ml/min)
  • males with testosterone deficiency, and post-menopausal females will be excluded

研究组 & 干预措施

darunavir ritonavir raltegravir

Experimental

experimental

干预措施: darunavir ritonavir raltegravir (Drug)

atripla

Active Comparator

comparator

干预措施: atripla (Drug)

结局指标

主要结局

Vitamin D levels and bone density

时间窗: 48 weeks

collection of vitamin d levels and bone density measured before and at end of 48 weeks

次要结局

  • viral load and CD 4 count(48 weeks)

研究者

申办方类型
其他

标识符

NCT 编号
NCT01343225
其他研究编号
IISP # 38879

日期

首次提交
(15年前)
首次发布
(15年前)
主要完成日期
研究完成日期
最近核实
最近更新
(15年前)

监管与共享

FDA 监管药物
否
是否有结果
否

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