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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Atherosclerosis; HIV Infections	Drug: Rosiglitazone maleate; Drug: Placebo	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	50 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
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
Study Start Date :	June 2003
Actual Primary Completion Date :	December 2009
Actual Study Completion Date :	December 2009

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: 1; The first group will receive 8 mg of the study drug (rosiglitazone).	Drug: Rosiglitazone maleate; See Detailed Description.
Placebo Comparator: 2; The second group will be given a placebo.	Drug: Placebo; See detailed description.

Outcome Measures

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Primary Outcome Measures :

1. Carotid intima media thickness (IMT) [ Time Frame: 1 year ]

Secondary Outcome Measures :

1. Changes in glucose metabolism [ Time Frame: 1 year ]
2. Changes in concentrations of blood lipids [ Time Frame: 1 year ]
3. Changes in C-reactive protein [ Time Frame: 1 year ]
4. Changes in pre-inflammatory cytokines (MCP-1, IL-6) and adipocytokines (RBP-4, adiponectin) [ Time Frame: 1 year ]

Eligibility Criteria

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Ages Eligible for Study:	30 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6

Sponsors and Collaborators

University of British Columbia

Investigators

Principal Investigator:	Greg Bondy, MD	University of British Columbia

More Information

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Additional Information:

Related Info 

Responsible Party:	Dr. Greg Bondy, University of British Columbia
ClinicalTrials.gov Identifier:	NCT00143624 History of Changes
Other Study ID Numbers:	P02-0086; CTN 178
First Posted:	September 2, 2005
Last Update Posted:	December 9, 2009
Last Verified:	December 2009

Keywords provided by University of British Columbia:

Treatment Experienced; HIV Metabolic Syndrome; Atherosclerosis in HIV

Additional relevant MeSH terms:

HIV Infections; Atherosclerosis; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Immunologic Deficiency Syndromes; Immune System Diseases	Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Maleic acid; Rosiglitazone; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents; Physiological Effects of Drugs