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

This study has been terminated.
(Sponsor has withdrawn the funding)
CIHR Canadian HIV Trials Network
Information provided by:
University of British Columbia Identifier:
First received: April 30, 2008
Last updated: August 24, 2009
Last verified: August 2009
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.

Condition Intervention Phase
HIV Infections
Drug: Rosuvastatin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Average total thickness (a composite of carotid intima media thickness and total plaque area) [ Time Frame: 96 weeks ]

Secondary Outcome Measures:
  • Carotid Intima Media Thickness, Total Plaque Area, Lipids [ Time Frame: 96 weeks ]

Estimated Enrollment: 250
Study Start Date: April 2008
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
10 mg/day rosuvastatin for 96 weeks
Drug: Rosuvastatin
10 mg/day rosuvastatin
Other Name: Crestor
Placebo Comparator: 2
Drug: Placebo
Placebo, 10 mg a day for 96 weeks

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.

Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00673582

Canada, British Columbia
The St. Paul's Hospital HIV Metabolic Clinic & The BC Centre for Excellence in HIV/AIDS
Vancouver, British Columbia, Canada, V6Z 1Y6
Sponsors and Collaborators
University of British Columbia
CIHR Canadian HIV Trials Network
Principal Investigator: Greg Bondy, MD University of British Columbia
Study Director: Marianne Harris, MD University of British Columbia
Study Director: Marek Smeija, MD University of British Columbia
Study Director: Joel Singer, MD University of British Columbia
Study Director: G.B. John Mancini, MD University of British Columbia
Study Director: Sammy Chan, MD University of British Columbia
Study Director: Julio Montaner, MD University of British Columbia
  More Information

Responsible Party: Dr. Greg Bondy, University of British Columbia Identifier: NCT00673582     History of Changes
Other Study ID Numbers: H07-00213
Study First Received: April 30, 2008
Last Updated: August 24, 2009

Keywords provided by University of British Columbia:
Intima Media Thickness
Plaque Area

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Rosuvastatin Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents processed this record on May 22, 2017