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.

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.

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

Adverse event (AE) data was collected during study involvement and for 144 weeks post completion of last study visit (up to 240 weeks).

Standard definitions used