Study Stopped
Sponsor has withdrawn the funding
Effectiveness of Rosuvastatin at Preventing the Progression of Atherosclerosis in HIV Positive Patients
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
2 other identifiers
interventional
250
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2008
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 30, 2008
CompletedFirst Posted
Study publicly available on registry
May 7, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedAugust 25, 2009
August 1, 2009
4.7 years
April 30, 2008
August 24, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Average total thickness (a composite of carotid intima media thickness and total plaque area)
96 weeks
Secondary Outcomes (1)
Carotid Intima Media Thickness, Total Plaque Area, Lipids
96 weeks
Study Arms (2)
1
EXPERIMENTAL10 mg/day rosuvastatin for 96 weeks
2
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- HIV positive, at least one cardiovascular disease risk factor
You may not qualify if:
- Diabetes
- Previous vascular disease
- Muscular disease
- Current use of other lipid lowering therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of British Columbialead
- AstraZenecacollaborator
- CIHR Canadian HIV Trials Networkcollaborator
Study Sites (1)
The St. Paul's Hospital HIV Metabolic Clinic & The BC Centre for Excellence in HIV/AIDS
Vancouver, British Columbia, V6Z 1Y6, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 30, 2008
First Posted
May 7, 2008
Study Start
April 1, 2008
Primary Completion
December 1, 2012
Study Completion
March 1, 2013
Last Updated
August 25, 2009
Record last verified: 2009-08