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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00143624
• Other study ID #: P02-0086
• Secondary ID: CTN 178
• Status: Completed
• Phase: N/A
• First received: August 31, 2005
• Last updated: December 8, 2009
• Start date: June 2003
• Est. completion date: December 2009

Study information

• Verified date: December 2009
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• HIV Infections

Intervention

Drug:
• Rosiglitazone maleate
See Detailed Description.
• Placebo
See detailed description.

Locations

Country	Name	City	State
Canada	St. Paul's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Carotid intima media thickness (IMT)		1 year	No
Secondary	Changes in glucose metabolism		1 year	No
Secondary	Changes in concentrations of blood lipids		1 year	No
Secondary	Changes in C-reactive protein		1 year	No
Secondary	Changes in pre-inflammatory cytokines (MCP-1, IL-6) and adipocytokines (RBP-4, adiponectin)		1 year	No

External Links

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