NCT00908011

Brief Summary

This study involves comparing the effectiveness of treatments in HIV positive patients who may be predisposed to heart attack or stroke. The investigators will evaluate the effectiveness of two drugs, often prescribed by doctors to these patients, at lowering cholesterol and thereby making the patient less them less vulnerable to suffering a heart attack or stroke. The investigators believe that the addition of a second drug, from a different class of cholesterol lowering medications, will improve the outcome of the patients by lowering cholesterol.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 25, 2009

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
1 year until next milestone

Results Posted

Study results publicly available

January 1, 2016

Completed
Last Updated

January 1, 2016

Status Verified

November 1, 2015

Enrollment Period

5.5 years

First QC Date

May 21, 2009

Results QC Date

November 30, 2015

Last Update Submit

November 30, 2015

Conditions

HypercholesterolemiaHIV Infections

Keywords

HypercholesterolemiaHIVEzetimibeStatinApolipoprotein B100/Apolipoprotein A1 ratio

Outcome Measures

Primary Outcomes (1)

  • The Primary Endpoint is the Difference in Final Value of Serum Apolipoprotein B Between Participants Treated With Rosuvastatin Versus Participants Treated With Both Rosuvastatin and Ezetimibe.

    3 months from baseline

Secondary Outcomes (2)

  • Percent Change in Apolipoprotein B, Percent and Absolute Change Total Cholesterol, LDL, HDL, Triglycerides, Apolipoprotein A1, apolipoproteinB/apoliporoteinA1 Ratio and C-reactive Protein

    3 months from baseline

  • Assessment of Safety Parameters, Specifically Incidence of Complications as Measured by an Increase in AST &/or ALT ≥3-fold ULN & a CK ≥10-fold ULN

    3 months from baseline

Study Arms (2)

Ezetimibe

ACTIVE COMPARATOR

10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)

Drug: Ezetimibe

Standard Care

ACTIVE COMPARATOR

Increased dose of rosuvastatin to 20mg/day

Drug: Rosuvastatin (standard care)

Interventions

EzetimibeDRUG

10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)- tablet, orally, 10mg/day for 12 weeks

Also known as: Ezetrol
Ezetimibe
Rosuvastatin (standard care)DRUG

Increased dose of rosuvastatin to 20mg/day

Also known as: Crestor
Standard Care

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV positive
  • currently taking 10mg of rosuvastatin
  • recent (within three months) fasting lipid profile in which the serum total cholesterol to HDL ratio is \>5.0

You may not qualify if:

  • Previous adverse reaction to ezetimibe
  • taken ezetimibe within 30 days of starting the study
  • history of vascular disease
  • allergic reaction or muscle problems while taking any statin
  • currently taking other lipid lowering medications (i.e. a fibrates or cholestyramine)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Paul's Hospital HIV Immunodeficiency/Metabolic Clinic

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

MeSH Terms

Conditions

HypercholesterolemiaHIV Infections

Interventions

EzetimibeRosuvastatin CalciumStandard of Care

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

AzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsSulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Results Point of Contact

Title
Dr. Greg Bondy
Organization
St. Paul's Hospital/University of B.C.
gbondy@providencehealth.bc.ca
604-806-8192

Study Officials

  • Greg Bondy, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2009

First Posted

May 25, 2009

Study Start

June 1, 2009

Primary Completion

December 1, 2014

Study Completion

January 1, 2015

Last Updated

January 1, 2016

Results First Posted

January 1, 2016

Record last verified: 2015-11

Locations

CA(1)