Does Rosuvastatin Delay Progression of Atherosclerosis in HIV
- Registration Number
- NCT01813357
- Lead Sponsor
- Bayside Health
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo sugar pill that is encapsulated so as to appear identical to the active agent Rosuvastatin Rosuvastatin Rosuvastatin 20mg daily
- Primary Outcome Measures
Name Time Method Progression of Carotid Intima Media Thickness Baseline to week 96 Carotid intima media thickness will be measured by ultrasonography and the change from baseline to week 96 calculated
- Secondary Outcome Measures
Name Time Method Rates of Adverse Events Will be assessed every 12 weeks and formally reported at 96 weeks of followup Number of participants with adverse events in total and also the number of participants with adverse events thought secondary to the study medication
Trial Locations
- Locations (2)
Hospitaux Universitaires de Geneve
🇨🇭Geneve, Switzerland
Alfred Hospital
🇦🇺Melbourne, Victoria, Australia