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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
84
encapsulated tablet 20mg daily
Placebo arm included to maintain blinding
Alfred Hospital
Melbourne, Victoria, Australia
Hospitaux Universitaires de Geneve
Geneva, Switzerland
Progression of Carotid Intima Media Thickness
Carotid intima media thickness will be measured by ultrasonography and the change from baseline to week 96 calculated
Time frame: Baseline to week 96
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
Time frame: Will be assessed every 12 weeks and formally reported at 96 weeks of followup
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