|
|
|
|
|
|
Sponsored by: |
University of British Columbia |
Information provided by: | University of British Columbia |
ClinicalTrials.gov Identifier: | NCT00143624 |
This trial will study the effect of rosiglitazone on the progression of atherosclerosis (hardening of blood vessels) through improvements of the sugar and fat metabolism (body buildup, breakdown and excretion of sugar and fat).
Participants will be randomly assigned to one of two groups: the first group will receive 8 mg of the study drug and the second group will be given a placebo, though neither group will know which formulation they are receiving. The study will follow both groups for one year, during which it will measure changes in blood vessel composition and activity, sugar metabolism, concentration of blood fat, and body fat distribution. This single-site study aims to enroll 50 participants.
Condition | Intervention |
Atherosclerosis HIV Infections |
Drug: Rosiglitazone maleate Drug: Placebo |
MedlinePlus related topics: | AIDS |
ChemIDplus related topics: | Rosiglitazone Rosiglitazone Maleate Dextrose Lipids |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment |
Official Title: | Effect of Rosiglitazone Maleate (Avandia®) on Carotid Intima Media Thickness, Brachial Artery Reactivity, Glucose Metabolism, Blood Lipid Concentrations, Body Fat Distribution, and Biochemical Markers of Cardiovascular Risk in Patients With the HIV Metabolic Syndrome |
Estimated Enrollment: | 50 |
Study Start Date: | June 2003 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
The first group will receive 8 mg of the study drug (rosiglitazone).
|
Drug: Rosiglitazone maleate
See Detailed Description.
|
2: Placebo Comparator
The second group will be given a placebo.
|
Drug: Placebo
See detailed description.
|
Ages Eligible for Study: | 30 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sophie Geeraerts | 604-806-8758 | sophie@hivnet.ubc.ca |
Canada, British Columbia | |||||
St. Paul's Hospital | Recruiting | ||||
Vancouver, British Columbia, Canada, V6Z 1Y6 | |||||
Contact: Sophie Geeraerts 604-806-8758 sophie@hivnet.ubc.ca | |||||
Contact: Marianne Harris, MD, CCFP 604-806-8771 | |||||
Principal Investigator: Greg Bondy, MD |
University of British Columbia |
Principal Investigator: | Greg Bondy, MD | University of British Columbia |
Related Info 
  |
Responsible Party: | University of British Columbia ( Dr. Greg Bondy ) |
Study ID Numbers: | P02-0086, CTN 178 |
First Received: | August 31, 2005 |
Last Updated: | September 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00143624 |
Health Authority: | Canada: Health Canada |
|
|
|
|
|