Rosiglitazone (Avandia®) Treatment in HIV: Its Effect on Blood Vessels
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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 (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 |
- Carotid intima media thickness (IMT) [ Time Frame: 1 year ]
- Changes in glucose metabolism [ Time Frame: 1 year ]
- Changes in concentrations of blood lipids [ Time Frame: 1 year ]
- Changes in C-reactive protein [ Time Frame: 1 year ]
- Changes in pre-inflammatory cytokines (MCP-1, IL-6) and adipocytokines (RBP-4, adiponectin) [ Time Frame: 1 year ]
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 30 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00143624
| Canada, British Columbia | |
| St. Paul's Hospital | |
| Vancouver, British Columbia, Canada, V6Z 1Y6 | |
| Principal Investigator: | Greg Bondy, MD | University of British Columbia |
More Information
Additional Information:
| 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 Submitted: | August 31, 2005 |
| 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 |