Statin Therapy to Improve Inflammation and Atherosclerosis in HIV Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Coronary and Aortic Plaque Inflammation
研究概览
简要总结
In HIV patients, statin therapy will attenuate plaque inflammation, thus, making plaques less vulnerable, will deter plaque progression, and improve endothelial function. In addition to known cholesterol-lowering and C-reactive protein lowering effects, immunomodulatory effects of statins will lead to a shift from pro-inflammatory monocyte and T cell subsets to less atherogenic subpopulations.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Atorvastatin
20 mg PO QD for the first 3 months, followed by 40 mg PO QD for the final 9 months.
干预措施: atorvastatin (Drug)
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Coronary and Aortic Plaque Inflammation
时间窗: Measured at baseline and 1 year
12 month change in mean FDG-PET TBR (18-fluorodeoxyglucose positron emission tomography target-to-background ratio)
次要结局
- Endothelial Function(1 year)
- Immune Function(Measured at baseline and 1 year)
- Liver Function Tests (LFTs)(Measured at baseline, 1, 3, 6, 9, and 12 months)
- Plaque Progression(Measured at baseline and 1 year)
- Lipid Profile(Measured at baseline and 1 year)
- C-reactive Protein (CRP)(Measured at baseline and 1 year)
- Adipocytokines(Measured at baseline and 1 year)
研究者
Steven K. Grinspoon, MD
Professor of Medicine, Harvard Medical School
Massachusetts General Hospital