Randomized, Multicentre, Double- Blind, Placebo Controlled Trial of Rosuvastatin 10 mg for Inhibition of Atherosclerosis Progression Assessed by Carotid Artery Ultrasound in HIV-positive Patients Treated With Antiretrovirals
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Average total thickness (a composite of carotid intima media thickness and total plaque area)
Study Overview
Brief Summary
Rosuvastatin is a drug used to lower cholesterol, which also has other cardiovascular benefits. The goal of this project is to determine if rosuvastatin is effective at slowing the development of heart disease in people with HIV. We expect that after 2 years of treatment people treated with rosuvastatin will show significantly better results than people treated with a placebo.
Detailed Description
HIV+ patients with at least one cardiovascular risk factor will be randomized to either rosuvastatin 10mg/day or placebo for a period of 96 weeks. B-mode carotid ultrasound will assess the primary outcome measure of average total thickness (a composite measurement of intima media thickness and total plaque area) at baseline, 24, 48, 72 and 96 weeks. We hypothesize that rosuvastatin will be significantly more effective with respect to inhibition of change in average total thickness between baseline and 96 weeks compared to placebo.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 35 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •HIV positive, at least one cardiovascular disease risk factor
Exclusion Criteria
- •Previous vascular disease
- •Muscular disease
- •Current use of other lipid lowering therapy
Arms & Interventions
1
10 mg/day rosuvastatin for 96 weeks
Intervention: Rosuvastatin (Drug)
2
Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Average total thickness (a composite of carotid intima media thickness and total plaque area)
Time Frame: 96 weeks
Secondary Outcomes
- Carotid Intima Media Thickness, Total Plaque Area, Lipids(96 weeks)