Rosiglitazone (Avandia®) Treatment in HIV: Its Effect on Blood Vessels
This study has been completed.
Sponsor:
University of British Columbia
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00143624
First received: August 31, 2005
Last updated: December 8, 2009
Last verified: December 2009
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Purpose
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 | Intervention |
|---|---|
|
Atherosclerosis HIV Infections |
Drug: Rosiglitazone maleate Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
Resource links provided by NLM:
Further study details as provided by University of British Columbia:
Primary Outcome Measures:
- Carotid intima media thickness (IMT) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Changes in glucose metabolism [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Changes in concentrations of blood lipids [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Changes in C-reactive protein [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Changes in pre-inflammatory cytokines (MCP-1, IL-6) and adipocytokines (RBP-4, adiponectin) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | June 2003 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 30 Years to 70 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00143624
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
Additional Information:
No publications provided
| Responsible Party: | Dr. Greg Bondy, University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT00143624 History of Changes |
| Other Study ID Numbers: | P02-0086, CTN 178 |
| Study First Received: | August 31, 2005 |
| Last Updated: | December 8, 2009 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of British Columbia:
|
Treatment Experienced HIV Metabolic Syndrome Atherosclerosis in HIV |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Atherosclerosis Metabolic Syndrome X Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Arteriosclerosis |
Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Maleic acid Rosiglitazone Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on March 07, 2013
