Randomised Comparative Study of the Efficacy and Safety of Rosuvastatin and Pravastatin in Dyslipidemic Patients Treated With Antiretroviral Agents. Anrs 126
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Compare the change in LDL cholesterol between D0 and D45, in patients receiving rosuvastatin (10 mg/day) or pravastatin (40 mg/day) and treated by antiretroviral agents including a boosted protease inhibitor on D45.
研究概览
简要总结
In HIV hypercholesterolemic patients treated with protease inhibitors, some drugs of the statin group are used to control cholesterol level. New and potentially more efficient statins may interfere with protease inhibitors and hence loose a part of their activity. They have thus to be compared with a more established drug of the same class (e.g. pravastatin). The protocol compares the efficacy and safety of rosuvastatin and pravastatin.
详细描述
The study compares the efficacy and safety of rosuvastatin and pravastatin among dyslipidemic HIV-seropositive patients treated with antiretroviral agents including a boosted protease inhibitor.
It is an open, multicenter, randomised trial, with two parallel groups comparing rosuvastatin with pravastatin.
Statins are administered from D0, with a single daily dose in the morning, for 45 consecutive days.
The duration of the study for each patient will be 45 days not including the preselection period (maximum 15 days).
The primary end-point compares the change in LDL cholesterol between D0 and D45, in patients receiving rosuvastatin (10 mg/day) or pravastatin (40 mg/day) and treated by antiretroviral agents including a boosted Protease Inhibitor.
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
- None
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
- •Fasting LDL cholesterol over 4.1 mmol/L (1.6 g/l)
- •Blood triglycerides over 8.8 mmol/L (8 g/l)
- •HIV-1 infection
- •Viral load above or equal to 10.000 copies/ml
- •Stable antiretroviral regimen for past two months
排除标准
- •Coronary disease
- •Genetic muscular disease
- •CPK over 5N
- •Hepatic or renal insufficiency
- •Alcohol intake more than 40g/d
- •Hypothyroidism
- •Pregnancy and breast feeding
结局指标
主要结局
Compare the change in LDL cholesterol between D0 and D45, in patients receiving rosuvastatin (10 mg/day) or pravastatin (40 mg/day) and treated by antiretroviral agents including a boosted protease inhibitor on D45.
次要结局
- Changes in triglycerides and HDL cholesterol on D45
- Percentage of patients with a normal value of LDL cholesterol, HDL cholesterol and triglycerides on D45 Clinical and biological safety parameters of rosuvastatin and pravastatin
- Distribution profile of the diameter of LDL cholesterol particles
- Cmin of rosuvastatin and pravastatin on D15
- Cmin of protease inhibitors on D15.