Does Rosuvastatin Delay Progression of Atherosclerosis in HIV

Bayside Health

Status and phase: Completed; Phase 4

Conditions: HIV; Cardiovascular Disease

Treatments: Other: Placebo; Drug: Rosuvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01813357

AH-491/12

ACTRN12612001082897 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

sugar pill that is encapsulated so as to appear identical to the active agent

Treatment:

Other: Placebo

Rosuvastatin

Experimental group

Description:

Rosuvastatin 20mg daily

Treatment:

Drug: Rosuvastatin