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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00143624

Enrollment

Registered

2005-09-02

Start date

2003-06-30

Completion date

2009-12-31

Last updated

2009-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, HIV Infections

Keywords

Treatment Experienced, HIV Metabolic Syndrome, Atherosclerosis in HIV

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.

Interventions

DRUGRosiglitazone maleate

See Detailed Description.

DRUGPlacebo

See detailed description.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

30 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Carotid intima media thickness (IMT)	1 year

Secondary

Measure	Time frame
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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026