Effectiveness of Rosuvastatin at Preventing the Progression of Atherosclerosis in HIV Positive Patients
Information source: University of British Columbia
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atherosclerosis; HIV Infections
Intervention: Rosuvastatin (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of British Columbia Official(s) and/or principal investigator(s):
Greg Bondy, MD, Principal Investigator, Affiliation: University of British Columbia
Marianne Harris, MD, Study Director, Affiliation: University of British Columbia
Marek Smeija, MD, Study Director, Affiliation: University of British Columbia
Joel Singer, MD, Study Director, Affiliation: University of British Columbia
G.B. John Mancini, MD, Study Director, Affiliation: University of British Columbia
Sammy Chan, MD, Study Director, Affiliation: University of British Columbia
Julio Montaner, MD, Study Director, Affiliation: University of British Columbia
Overall contact:
Marianne Harris, MD, Phone: 604-806-8771, Email: mharris@cfenet.ubc.ca
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.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Average total thickness (a composite of carotid intima media thickness and total plaque area)
Secondary outcome: Carotid Intima Media Thickness, Total Plaque Area, Lipids
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
Minimum age: 35 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Marianne Harris, MD, Phone: 604-806-8771, Email: mharris@cfenet.ubc.ca
The St. Paul's Hospital HIV Metabolic Clinic & The BC Centre for Excellence in HIV/AIDS, Vancouver, British Columbia V6Z 1Y6, Canada; Recruiting
Greg Bondy, MD, Principal Investigator
Additional Information
Starting date: April 2008
Ending date: March 2013
Last updated: August 6, 2008
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