Effectiveness of Rosuvastatin at Preventing the Progression of Atherosclerosis in HIV Positive Patients

August 24, 2009 updated by: University of British Columbia

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • The St. Paul's Hospital HIV Metabolic Clinic & The BC Centre for Excellence in HIV/AIDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

33 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Placebo
Drug: Placebo
Placebo, 10 mg a day for 96 weeks
Experimental: 1
10 mg/day rosuvastatin for 96 weeks
Drug: Rosuvastatin
10 mg/day rosuvastatin
Other Names:
  • Crestor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Average total thickness (a composite of carotid intima media thickness and total plaque area)
Time Frame: 96 weeks
96 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Carotid Intima Media Thickness, Total Plaque Area, Lipids
Time Frame: 96 weeks
96 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

AstraZeneca
CIHR Canadian HIV Trials Network

Investigators

  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

March 1, 2013

Study Registration Dates

First Submitted

April 30, 2008

First Submitted That Met QC Criteria

May 6, 2008

First Posted (Estimate)

May 7, 2008

Study Record Updates

Last Update Posted (Estimate)

August 25, 2009

Last Update Submitted That Met QC Criteria

August 24, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H07-00213
  • D3560L00059

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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