Rosiglitazone (Avandia®) Treatment in HIV: Its Effect on Blood Vessels
|ClinicalTrials.gov Identifier: NCT00143624|
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : December 9, 2009
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 or disease||Intervention/treatment||Phase|
|Atherosclerosis HIV Infections||Drug: Rosiglitazone maleate Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||June 2003|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2009|
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.
- Carotid intima media thickness (IMT) [ Time Frame: 1 year ]
- Changes in glucose metabolism [ Time Frame: 1 year ]
- Changes in concentrations of blood lipids [ Time Frame: 1 year ]
- Changes in C-reactive protein [ Time Frame: 1 year ]
- Changes in pre-inflammatory cytokines (MCP-1, IL-6) and adipocytokines (RBP-4, adiponectin) [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00143624
|Canada, British Columbia|
|St. Paul's Hospital|
|Vancouver, British Columbia, Canada, V6Z 1Y6|
|Principal Investigator:||Greg Bondy, MD||University of British Columbia|