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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
University of British Columbia


Information provided by (Responsible Party)
University of British Columbia
ClinicalTrials.gov Identifier
NCT00143624

First received: August 31, 2005
Last updated: December 8, 2009
Last Verified: December 2009
History of Changes
Purpose

Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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

Further study details as provided by University of British Columbia:

Primary Outcome Measures

  • Carotid intima media thickness (IMT) [ Time Frame: 1 year ]
Secondary Outcome Measures:
  • 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 ]

Enrollment: 50
Study Start Date: June 2003
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: 1
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.
Drug: Placebo

See detailed description.

Eligibility

Eligibility

Ages Eligible for Study: 30 Years to 70 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00143624

Locations

Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6

Sponsors and Collaborators

University of British Columbia

Investigators

Principal Investigator: Greg Bondy, MD University of British Columbia
More Information

More Information

Additional Information:

Related Info

Responsible Party: Dr. Greg Bondy, University of British Columbia  
ClinicalTrials.gov Identifier: NCT00143624   History of Changes  
Other Study ID Numbers: P02-0086  
  CTN 178  
Study First Received: August 31, 2005  
Last Updated: December 8, 2009  

Keywords provided by University of British Columbia:

Treatment Experienced
HIV Metabolic Syndrome
Atherosclerosis in HIV

Additional relevant MeSH terms:
HIV Infections
Atherosclerosis
Maleic acid
Rosiglitazone

ClinicalTrials.gov processed this data on October 18, 2017
This information is provided by ClinicalTrials.gov.