NCT01813357

Does Rosuvastatin Delay Progression of Atherosclerosis in HIV

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Bayside Health · Other Government
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• HIV
• Cardiovascular Disease

Interventions

Type	Name	Description
DRUG	Rosuvastatin	encapsulated tablet 20mg daily
OTHER	Placebo	Placebo arm included to maintain blinding

Timeline

• Start date: 2013-07-02
• Primary completion: 2018-05-17
• Completion: 2018-11-01
• First posted: 2013-03-19
• Last updated: 2020-08-28
• Results posted: 2020-08-28

Locations

2 sites across 2 countries: Australia, Switzerland