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

Not Applicable

Completed

• Conditions: Atherosclerosis; HIV Infections
• Interventions: Drug: Rosiglitazone maleate; Drug: Placebo

• Registration Number: NCT00143624
• Lead Sponsor: University of British Columbia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Study First Submitted: 2005-08-31
• Study First Submitted QC: 2005-08-31
• Study First Posted: 2005-09-02
• Status Verified: 2009-12
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Last Update Submitted: 2009-12-08
• Last Update Posted: 2009-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Rosiglitazone maleate	The first group will receive 8 mg of the study drug (rosiglitazone).
2	Placebo	The second group will be given a placebo.

Primary Outcome Measures

Name	Time	Method
Carotid intima media thickness (IMT)	1 year

Secondary Outcome Measures

Name	Time	Method
Changes in glucose metabolism	1 year
Changes in concentrations of blood lipids	1 year
Changes in C-reactive protein	1 year
Changes in pre-inflammatory cytokines (MCP-1, IL-6) and adipocytokines (RBP-4, adiponectin)	1 year

Trial Locations

Locations (1)

St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada