A Randomised, Double-Blind Study of Pravastatin for the Treatment of Hyperlipidaemia in Patients With HIV
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Between-group difference in time weighted change from baseline in fasting serum total cholesterol
研究概览
简要总结
This study is a randomised, placebo-controlled study of the effect of treatment with the HMG-CoA reductase inhibitor, pravastatin, in HIV-infected, protease inhibitor treated patients with high serum cholesterol. We hypothesise that pravastatin will result in greater reductions in cholesterol than placebo when used in conjunction with appropriate dietary advice.
详细描述
High serum cholesterol concentrations are commonly seen in HIV-infected patients treated with some protease inhibitor medications as part of long-term antiretroviral therapy for HIV. There is concern that these elevations in cholesterol may negatively impact on long-term risk of cardiovascular disease in this patient population. Pravastatin, a HMG-CoA reductase inhibitor, is commonly used to treat hypercholesterolaemia in the general population. We aim to examine the effect of 12 weeks therapy with 40mg pravastatin daily in conjunction with dietary advice in HIV-infected patients with elevated serum cholesterol on continued protease inhibitor therapy.
After 4 weeks of dietary advice, patients will be randomised to receive either pravastatin or placebo for 12 weeks. Assessments include fasting lipid and glycaemic parameters, measures of body composition and HIV disease, and surrogate markers for cardiovascular disease.
Although previous small studies of pravastatin in this field have been performed, none has done so in a randomised placebo controlled trial taking into account all the relevant measures.
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
- Double
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
- •Provide written informed consent to participate in the trial
- •HIV-1 sero-positive
- •Male/female >18 years age
- •Currently receiving HIV protease inhibitor therapy for > 12 weeks and unlikely to require change in existing regimen during the 16 week study period
- •Fasting cholesterol > 6.5 mmol/L (mean of 2 samples collected > 3 days apart)
排除标准
- •Any condition which may interfere with ability to comply with study
- •Gastrointestinal disorder which may affect drug absorption
- •Hypertension or congestive cardiac failure
- •Lactic acidemia (serum lactate level >2.2 mmol/L)
- •Any serious medical condition which may compromise the patient's safety, including pancreatitis or hepatitis within past 6 months
- •Active AIDS defining conditions
- •Concurrent therapy with any other lipid lowering agents, oral hypoglycaemics, anabolic steroids or insulin
结局指标
主要结局
Between-group difference in time weighted change from baseline in fasting serum total cholesterol
次要结局
- Includes: between-group difference in time weighted change: from wk 4 in fasting serum total cholesterol as well as from baseline in HDL-cholesterol and triglycerides; in total and regional body fat; in endothelial function