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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(Sponsor has withdrawn the funding)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:
ClinicalTrials.gov Identifier:
NCT00673582
First Posted: May 7, 2008
Last Update Posted: August 25, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
AstraZeneca
CIHR Canadian HIV Trials Network
Information provided by:
University of British Columbia
  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
Intervention Model: Parallel Assignment
Masking: Double (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
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

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr. Greg Bondy, University of British Columbia
ClinicalTrials.gov Identifier: NCT00673582     History of Changes
Other Study ID Numbers: H07-00213
D3560L00059
First Submitted: April 30, 2008
First Posted: May 7, 2008
Last Update Posted: August 25, 2009
Last Verified: August 2009

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

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