drugset / Trial / NCT01813357

Does Rosuvastatin Delay Progression of Atherosclerosis in HIV

NCT01813357 ↗

Phase 4 Completed 84 enrolled Bayside Health
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2013-07-02
Primary completion
2018-05-17
Completion
2018-11-01

Outcome

Missed primary endpoint

registry MEAN Placebo: 0.0062 (Standard Error 0.0039) mm MEAN Rosuvastatin: 0.004 (Standard Error 0.0036) mm analysis (superiority test); Placebo vs Rosuvastatin; p = 0.684 NCT01813357 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Rosuvastatin Small molecule 10 mg Oral
Subject Rosuvastatin Small molecule 20 mg Oral