Rosiglitazone (Avandia®) Treatment in HIV: Its Effect on Blood Vessels

This study has been completed.
Sponsor:
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00143624
First received: August 31, 2005
Last updated: December 8, 2009
Last verified: December 2009

August 31, 2005
December 8, 2009
June 2003
December 2009   (final data collection date for primary outcome measure)
Carotid intima media thickness (IMT) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Carotid intima media thickness (IMT)
Complete list of historical versions of study NCT00143624 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Changes in brachial artery activity
  • Changes in glucose metabolism
  • Changes in concentrations of blood lipids
  • Changes in body fat distribution
Not Provided
Not Provided
 
Rosiglitazone (Avandia®) Treatment in HIV: Its Effect on Blood Vessels
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Atherosclerosis
  • HIV Infections
  • Drug: Rosiglitazone maleate
    See Detailed Description.
  • Drug: Placebo
    See detailed description.
  • Experimental: 1
    The first group will receive 8 mg of the study drug (rosiglitazone).
    Intervention: Drug: Rosiglitazone maleate
  • Placebo Comparator: 2
    The second group will be given a placebo.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV-positive
  • Between 30 and 70 years of age
  • Elevated blood levels of fat
  • On two or more anti-HIV drugs for at least12 months in a row and unlikely to change anti-HIV therapy during the study
  • On stable regimen for at least 6 months for women taking oral contraceptive agents or hormone replacement
  • On a stable regimen for at least 6 months for men on testosterone replacement
  • If taking nevirapine, on therapy for at least 3 months with stable liver function tests

Exclusion Criteria:

  • Pregnancy and breastfeeding
  • Poorly controlled diabetes
  • Uncontrolled hypertension or clinical evidence of heart failure
  • Any serious medical conditions, including an active AIDS-defining condition, pancreatitis, or hepatitis within 6 months prior to the study
  • Laboratory abnormalities (see investigator)
  • On lipid lowering agents, insulin, anabolic steroids (except for testosterone at replacement doses), oral corticosteroids at greater than replacement doses, or growth hormones
  • History of liver reaction or severe edema associated with current thiazolidinedione
  • History of hypersensitivity to thiazolidinedione
Both
30 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00143624
P02-0086, CTN 178
No
Dr. Greg Bondy, University of British Columbia
University of British Columbia
Not Provided
Principal Investigator: Greg Bondy, MD University of British Columbia
University of British Columbia
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP