Does Rosuvastatin Delay Progression of Atherosclerosis in People With HIV Infection at Moderate Cardiovascular Risk? A Multicentre Randomized, Double Blind Placebo-controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Progression of Carotid Intima Media Thickness
研究概览
简要总结
This study is a randomised double blind placebo controlled trial comparing Rosuvastatin with placebo in HIV positive people who are at intermediate cardiovascular risk.
It is possible that HIV positive people will receive a greater benefit from statins because of their higher baseline levels of inflammation. Current Australian guidelines recommend initiation of statin therapy on the basis of cholesterol level and the presence of other risk factors for heart disease (such as diabetes) but do not take into account whether a patient is infected with HIV. This study aims to determine what benefit HIV infected people will receive from starting statin therapy earlier then currently recommended.
详细描述
Participants will be randomised to receive either the active agent (Rosuvastatin) or a placebo once daily for 96 weeks.
Participants will undergo blood tests and ultrasounds of the arteries of the neck (carotid intima media thickness) prior to starting Rosuvastatin and then after 1 and 2 years on the drug to determine what effect it has on markers of inflammation, cholesterol levels and thickness of blood vessels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Moderate cardiovascular disease (CVD) risk, (10-15% 10 year risk of CVD)
- •HIV positive
- •Stable combination anti-retroviral therapy (cART) with plasma HIV viral load <200copies/ml for ≥ 6 months
排除标准
- •Recommended use of lipid lowering therapy according to Australian guidelines
- •Prior use of statin, fibrate, ezetimibe within the last six months
- •Contraindication to statin use
研究组 & 干预措施
Placebo
sugar pill that is encapsulated so as to appear identical to the active agent
干预措施: Placebo (Other)
Rosuvastatin
Rosuvastatin 20mg daily
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
Progression of Carotid Intima Media Thickness
时间窗: Baseline to week 96
Carotid intima media thickness will be measured by ultrasonography and the change from baseline to week 96 calculated
次要结局
- Rates of Adverse Events(Will be assessed every 12 weeks and formally reported at 96 weeks of followup)