Does rosuvastatin delay progression of atherosclerosis in people with HIV infection at moderate cardiovascular risk? A randomized, multicentre placebo controlled trial

Does rosuvastatin delay progression of atherosclerosis in people with HIV infection at moderate cardiovascular risk? A randomized, placebo-controlled trial

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612001082897

Enrollment

Registered

2012-10-09

Start date

2013-09-02

Completion date

2016-06-30

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Participants: 110 HIV positive patients who are currently taking anti-HIV medications, have well controlled HIV and are at moderate risk for heart disease (and thus do not currently qualify for statin therapy) will be recruited from the Infectious Diseases Clinic of the Alfred Hospital. Methods: Participants will be randomised to receive either the active agent (Rosuvastatin) or a placebo once daily for 96 weeks. Rosuvastatin is a statin licensed for use in Australia to control high cholesterol levels and prevent heart disease in patients at high risk. Participants will undergo blood tests and ultrasounds of the arteries of the neck 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 (which relates to damage of blood vessels supplying the heart and thus the risk of heart attacks) Analysis: The main outcome will be to compare the rate at which blood vessels thicken in the participants receiving rosuvastatin compared with those receiving placebo. We will also compare the amount of inflammation (based on blood tests) in each group and the presence of any side effects. Significance By showing that there are advantages to starting statin therapy earlier then currently recommended in people with HIV infection it may be possible to reverse some of the increased risks of heart attacks and strokes seen in these patients.

Interventions

Half the participants will receive a single 20mg Rosuvastatin tablet, orally daily for 96 weeks or an identical placebo. The tablet will be encapsulated in a Gelatin capsule that is identical in appearance, taste etc to the placebo.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Adults with proven HIV infection who are on a stable combination anti-retroviral therapy regimen with a plasma HIV viral load < 200 copies/ml for > six months AND who are at moderate cardiovascular risk , as estimated by a Framingham Risk score of 10-15% 10 year risk of cardiovascular disease

Exclusion criteria

- Fullfilling any current indication for lipid lowering therapy - Any contraindication to rosuvastatin therapy (including previous allergy, pregnancy, myopathy, creatinine clearance <30ml/min) - Use of contraindicated concurrent medications (cyclosporine, Gemfibrozil, Niacin, Fusidic acid)

Outcome results