Official Title: “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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: December 2012

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.

Intervention(s) in this Clinical Trial

• Drug: Rosuvastatin
  • 10 mg/day rosuvastatin
• Drug: Placebo
  • Placebo, 10 mg a day for 96 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • 10 mg/day rosuvastatin for 96 weeks
• Placebo Comparator: 2
  • Placebo

Primary Measures

• Average total thickness (a composite of carotid intima media thickness and total plaque area)
  • Time Frame: 96 weeks
    Safety Issue?: No

Secondary Measures

• Carotid Intima Media Thickness, Total Plaque Area, Lipids
  • Time Frame: 96 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 35 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of British Columbia

Overall Clinical Trial Officials and Contacts

Greg Bondy, MD Principal Investigator University of British Columbia  

Overall Contact: Marianne Harris, MD 604-806-8771 mharris@cfenet.ubc.ca

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00673582

Study ID Number: H07-00213

ClinicalTrials.gov Identifier: NCT00673582

Health Authority: Canada: Health Canada