Rosiglitazone (Avandia®) Treatment in HIV: Its Effect on Blood Vessels
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|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|
- Carotid intima media thickness (IMT) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Changes in glucose metabolism [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Changes in concentrations of blood lipids [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Changes in C-reactive protein [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Changes in pre-inflammatory cytokines (MCP-1, IL-6) and adipocytokines (RBP-4, adiponectin) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||June 2003|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
The first group will receive 8 mg of the study drug (rosiglitazone).
Drug: Rosiglitazone maleate
See Detailed Description.
Placebo Comparator: 2
The second group will be given a placebo.
See detailed description.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00143624
|Canada, British Columbia|
|St. Paul's Hospital|
|Vancouver, British Columbia, Canada, V6Z 1Y6|
|Principal Investigator:||Greg Bondy, MD||University of British Columbia|