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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00673582
• Other study ID #: H07-00213
• Secondary ID: D3560L00059
• Status: Terminated
• Phase: Phase 4
• First received: April 30, 2008
• Last updated: August 24, 2009
• Start date: April 2008
• Est. completion date: March 2013

Study information

• Verified date: August 2009
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 250
• Est. completion date: March 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• HIV Infections

Intervention

Drug:
• Rosuvastatin
10 mg/day rosuvastatin
• Placebo
Placebo, 10 mg a day for 96 weeks

Locations

Country	Name	City	State
Canada	The St. Paul's Hospital HIV Metabolic Clinic & The BC Centre for Excellence in HIV/AIDS	Vancouver	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
University of British Columbia	AstraZeneca, CIHR Canadian HIV Trials Network

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average total thickness (a composite of carotid intima media thickness and total plaque area)		96 weeks	No
Secondary	Carotid Intima Media Thickness, Total Plaque Area, Lipids		96 weeks	No