A Prospective, Randomized Study to Determine the Effect of Ezetimibe in Addition to Rosuvastatin on Lipids in Participants With the Hypercholesterolemia Associated With HIV Antiretroviral Therapy
Sponsor study identifier
interventional
43
1 country
1
Study Start
June 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2014
Actual (reported)Study Completion
January 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 21, 2009
Actual (reported)May 25, 2009
Actual (reported)June 2009
Date type not reportedThis date has not been verified as actual or estimated.
December 2014
Actual (reported)January 2015
Actual (reported)January 1, 2016
Actual (reported)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
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
10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)
Increased dose of rosuvastatin to 20mg/day
10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)- tablet, orally, 10mg/day for 12 weeks
Increased dose of rosuvastatin to 20mg/day
St. Paul's Hospital HIV Immunodeficiency/Metabolic Clinic
Vancouver, British Columbia, V6Z 1Y6, Canada
Greg Bondy, MD
University of British Columbia
43 participants (actual enrollment reported by the registry).
First Submitted
May 21, 2009
First Posted
May 25, 2009
Study Start
June 2009
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
December 2014
Actual (reported)Study Completion
January 2015
Actual (reported)Last Updated
January 1, 2016
Results First Posted
January 1, 2016
Record last verified: 2015-11
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Source: ClinicalTrials.gov.
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