Does Rosuvastatin Delay Progression of Atherosclerosis in HIV

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-02

Study Completion Date

2018-11-01

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.

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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.

Conditions

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HIV Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo arm included to maintain blinding

Rosuvastatin

Rosuvastatin 20mg daily

Group Type EXPERIMENTAL

Rosuvastatin

Intervention Type DRUG

encapsulated tablet 20mg daily

Interventions

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Rosuvastatin

encapsulated tablet 20mg daily

Intervention Type DRUG

Placebo

Placebo arm included to maintain blinding

Intervention Type OTHER

Other Intervention Names

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Brand name: Crestor Sugar Pill

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No