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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Atherosclerosis, HIV Infections

Intervention / Treatment
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* Drug: Rosiglitazone maleate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>The first group will receive 8 mg of the study drug (rosiglitazone). | Drug: Rosiglitazone maleate<br>* See Detailed Description.<br>|
| Placebo Comparator: 2<br>The second group will be given a placebo. | Drug: Placebo<br>* See detailed description.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carotid intima media thickness (IMT) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment Experienced, HIV Metabolic Syndrome, Atherosclerosis in HIV