Effectiveness of Rosuvastatin at Preventing the Progression of Atherosclerosis in HIV Positive Patients

Phase 4

Terminated

• Conditions: Atherosclerosis; HIV Infections
• Interventions: Drug: Rosuvastatin; Drug: Placebo

• Registration Number: NCT00673582
• Lead Sponsor: University of British Columbia

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 Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-30
• Study First Submitted QC: 2008-05-06
• Study First Posted: 2008-05-07
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-24
• Last Update Posted: 2009-08-25
• Primary Completion: 2012-12
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• HIV positive, at least one cardiovascular disease risk factor

Exclusion Criteria

• Diabetes
• Previous vascular disease
• Muscular disease
• Current use of other lipid lowering therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Rosuvastatin	10 mg/day rosuvastatin for 96 weeks
2	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Average total thickness (a composite of carotid intima media thickness and total plaque area)	96 weeks

Secondary Outcome Measures

Name	Time	Method
Carotid Intima Media Thickness, Total Plaque Area, Lipids	96 weeks

Trial Locations

Locations (1)

The St. Paul's Hospital HIV Metabolic Clinic & The BC Centre for Excellence in HIV/AIDS; 🇨🇦 Vancouver, British Columbia, Canada