Phase 4
N=84
Does Rosuvastatin Delay Progression of Atherosclerosis in HIV
HIV · Cardiovascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT01813357 ↗Enrolled (actual)
84
Serious AEs
15.5%
Results posted
Aug 2020
Primary outcome: Primary: Progression of Carotid Intima Media Thickness — 0.0062; 0.004 mm — p=0.684
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Rosuvastatin (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bayside Health
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression of Carotid Intima Media Thickness |
0.0062; 0.004 | 0.684 |
| SECONDARY Rates of Adverse Events |
22; 35 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01813357). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.