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

NCT ID: NCT00143624

Last Updated: 2009-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2009-12-31

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.

Conditions

Atherosclerosis; HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

The first group will receive 8 mg of the study drug (rosiglitazone).

Group Type: EXPERIMENTAL

Rosiglitazone maleate

Intervention Type: DRUG

See Detailed Description.

2

The second group will be given a placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

See detailed description.

Interventions

Rosiglitazone maleate

See Detailed Description.

Intervention Type: DRUG

Placebo

See detailed description.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

University of British Columbia

Principal Investigators

Greg Bondy, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

St. Paul's Hospital

Vancouver, British Columbia, Canada

Countries

Canada

Related Links

http://www.hivnet.ubc.ca

Related Info

Other Identifiers

CTN 178

Identifier Type: -

Identifier Source: secondary_id

P02-0086

Identifier Type: -

Identifier Source: org_study_id