NCT00844519已完成3 期
Effect of Maraviroc on Endothelial Function in HIV-Infected Patients
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Percent Change in FMD
研究概览
简要总结
The purpose of this study is to determine the potentially beneficial aspects of CCR5 inhibition on inflammation and endothelial function as measured by brachial artery reactivity in antiretroviral treated HIV patients with an undetectable viral load.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable antiretroviral therapy for at least 12 months
- •All plasma HIV RNA levels within the past year must be below level of detection (< 50 copies RNA/mL), although isolated single values > 50 but < 200 copies will be allowed.
- •Screening plasma HIV RNA levels < 50 copies RNA/mL
- •>90% adherence to therapy within the preceding 30 days, as determined by self-report
- •Females of childbearing potential must have a negative serum pregnancy test at screening and agree to use a double-barrier method of contraception throughout the study period.
排除标准
- •Ongoing or prior use of any integrase inhibitor or R5 inhibitor.
- •Patients who plan to modify existing antiretroviral therapy in the next 24 weeks for any reason
- •Serious illness requiring hospitalization or parental antibiotics within preceding 3 months
- •Concurrent or recent exposure to any immunomodulatory drugs
- •Advanced liver disease or active hepatitis B or C
- •Patients with systolic blood pressure <100/70
- •Starting or stopping statin therapy during the trial
研究组 & 干预措施
Maraviroc
Active Comparator
For subjects assigned to the maraviroc group, subjects will receive maraviroc at 300mg by mouth twice daily for 24 weeks in addition to taking their current anti-HIV medication. For subjects on ritonavir, the dose of maraviroc will be 150mg by mouth twice daily.
干预措施: Maraviroc (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Percent Change in FMD
时间窗: Baseline, 24 weeks
endothelial function as assessed by measured flow-mediated vasodilation (FMD) of the brachial artery
次要结局
未报告次要终点
研究者
研究点 (1)
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