Effectiveness of Rosuvastatin at Preventing the Progressi... | NCT00673582

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

NCT00673582

Sponsor

University of British Columbia

Status

Terminated

Last Update Posted

Aug 25, 2009Estimated

Enrollment

250Estimated

Phase

Phase 4

Conditions

Atherosclerosis
HIV Infections

Interventions

Rosuvastatin
Placebo

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
D3560L00059

Status Module

Record Verification Date

Aug 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor has withdrawn the funding

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Dec 2012Estimated

Completion Date

Mar 2013Estimated

First Submitted Date

Apr 30, 2008

First Submission Date that Met QC Criteria

May 6, 2008

First Posted Date

May 7, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 24, 2009

Last Update Posted Date

Aug 25, 2009Estimated

Name	Class
AstraZeneca	INDUSTRY
CIHR Canadian HIV Trials Network	NETWORK

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	10 mg/day rosuvastatin for 96 weeks	Drug: Rosuvastatin
2	Placebo Comparator	Placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rosuvastatin	Drug	10 mg/day rosuvastatin	1	Crestor

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Greg Bondy, MD	University of British Columbia	Principal Investigator
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 Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The St. Paul's Hospital HIV Metabolic Clinic & The BC Centre for Excellence in HIV/AIDS		Vancouver	British Columbia	V6Z 1Y6	Canada

Condition Browse Module

MeSH Terms

ID	Term
D050197	Atherosclerosis
D015658	HIV Infections

Ancestor Terms

ID	Term
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068718	Rosuvastatin Calcium

Ancestor Terms

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D005464	Fluorobenzenes

Browse Leaves

Not provided

Browse Branches

Not provided