Does Rosuvastatin Delay Progression of Atherosclerosis in HIV

Study Overview
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Brief Summary
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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
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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.

Official Title
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Does Rosuvastatin Delay Progression of Atherosclerosis in People With HIV Infection at Moderate Cardiovascular Risk? A Multicentre Randomized, Double Blind Placebo-controlled Trial

Conditions
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HIV, Cardiovascular Disease

Intervention / Treatment
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* Drug: Rosuvastatin
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>sugar pill that is encapsulated so as to appear identical to the active agent | Other: Placebo<br>* Placebo arm included to maintain blinding<br>* Other names: Sugar Pill;|
| Experimental: Rosuvastatin<br>Rosuvastatin 20mg daily | Drug: Rosuvastatin<br>* encapsulated tablet 20mg daily<br>* Other names: Brand name: Crestor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression of Carotid Intima Media Thickness | Carotid intima media thickness will be measured by ultrasonography and the change from baseline to week 96 calculated | Baseline to week 96 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of Adverse Events | Number of participants with adverse events in total and also the number of participants with adverse events thought secondary to the study medication | Will be assessed every 12 weeks and formally reported at 96 weeks of followup | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Cardiovascular disease, Inflammation, Statin