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OpenTrials
Completed

NCT Number: NCT01813357

Does Rosuvastatin Delay Progression of Atherosclerosis in HIV

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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Key information

Conditions

HIV Cardiovascular Disease Cardiovascular Diseases Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Alfred Hospital, Melbourne, Victoria, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rosuvastatin

Drug

encapsulated tablet 20mg daily

Other names: Brand name: Crestor

Placebo

Other

Placebo arm included to maintain blinding

Other names: Sugar Pill

Primary outcomes

  1. Progression of Carotid Intima Media Thickness

    Time frame: Baseline to week 96

    Carotid intima media thickness will be measured by ultrasonography and the change from baseline to week 96 calculated

Secondary outcomes

  1. Rates of Adverse Events

    Time frame: Will be assessed every 12 weeks and formally reported at 96 weeks of followup

    Number of participants with adverse events in total and also the number of participants with adverse events thought secondary to the study medication

Sponsors and collaborators

Lead sponsor

Bayside Health

Other Gov

Registry information

Official study title

Does Rosuvastatin Delay Progression of Atherosclerosis in People With HIV Infection at Moderate Cardiovascular Risk? A Multicentre Randomized, Double Blind Placebo-controlled Trial

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Mar 19, 2013
Registry last updated
Aug 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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