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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(Sponsor has withdrawn the funding)
Sponsor:
Collaborators:
AstraZeneca
CIHR Canadian HIV Trials Network
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00673582
First received: April 30, 2008
Last updated: August 24, 2009
Last verified: August 2009
History of Changes
  Purpose

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
Atherosclerosis
HIV Infections
 Drug: Rosuvastatin
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Carotid Intima Media Thickness, Total Plaque Area, Lipids [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]

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
Placebo
 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.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00673582

Locations
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
AstraZeneca
CIHR Canadian HIV Trials Network
Investigators
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

No publications provided

Responsible Party: Dr. Greg Bondy, University of British Columbia
ClinicalTrials.gov Identifier: NCT00673582     History of Changes
Other Study ID Numbers: H07-00213, D3560L00059
Study First Received: April 30, 2008
Last Updated: August 24, 2009
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Atherosclerosis
HIV Seropositivity
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013