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
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
-
Objectives
-
To determine the vitamin D status of African-American HIV patients who are HIV-treatment naïve.
-
To compare the effects of an efavirenz-containing regimen to a protease inhibitor regimen on 25-hydroxyvitamin D and 1,25 dihydroxyvitamin D3 levels.
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To compare the effect on bone density of a tenofovir- and efavirenz-containing regimen to a regimen that does not contain these drugs.
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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
干预措施: darunavir ritonavir raltegravir (Drug)
atripla
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
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
