Back to resultsEffectiveness of Rosuvastatin at Preventing the Progression of Atherosclerosis in HIV Positive Patients
Primary Purpose
Atherosclerosis, HIV Infections
Status
Terminated
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Rosuvastatin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Atherosclerosis focused on measuring Statins, Intima Media Thickness, Plaque Area
Eligibility 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
Sites / Locations
- The St. Paul's Hospital HIV Metabolic Clinic & The BC Centre for Excellence in HIV/AIDS
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
10 mg/day rosuvastatin for 96 weeks
Placebo
Outcomes
Primary Outcome Measures
Average total thickness (a composite of carotid intima media thickness and total plaque area)
Secondary Outcome Measures
Carotid Intima Media Thickness, Total Plaque Area, Lipids
Full Information
NCT ID
NCT00673582
First Posted
April 30, 2008
Last Updated
August 24, 2009
Sponsor
University of British Columbia
Collaborators
AstraZeneca, CIHR Canadian HIV Trials Network
1. Study Identification
Unique Protocol Identification Number
NCT00673582
Brief Title
Effectiveness of Rosuvastatin at Preventing the Progression of Atherosclerosis in HIV Positive Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Terminated
Why Stopped
Sponsor has withdrawn the funding
Study Start Date
April 2008 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
March 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of British Columbia
Collaborators
AstraZeneca, CIHR Canadian HIV Trials Network
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis, HIV Infections
Keywords
Statins, Intima Media Thickness, Plaque Area
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
10 mg/day rosuvastatin for 96 weeks
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
Crestor
Intervention Description
10 mg/day rosuvastatin
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, 10 mg a day for 96 weeks
Primary Outcome Measure Information:
Title
Average total thickness (a composite of carotid intima media thickness and total plaque area)
Time Frame
96 weeks
Secondary Outcome Measure Information:
Title
Carotid Intima Media Thickness, Total Plaque Area, Lipids
Time Frame
96 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Greg Bondy, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marianne Harris, MD
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Marek Smeija, MD
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Joel Singer, MD
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
G.B. John Mancini, MD
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sammy Chan, MD
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Julio Montaner, MD
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
Facility Information:
Facility Name
The St. Paul's Hospital HIV Metabolic Clinic & The BC Centre for Excellence in HIV/AIDS
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Rosuvastatin at Preventing the Progression of Atherosclerosis in HIV Positive Patients
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