Rosiglitazone (Avandia®) Treatment in HIV: Its Effect on Blood Vessels
NCT ID: NCT00143624
Last Updated: 2009-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2003-06-30
2009-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
The first group will receive 8 mg of the study drug (rosiglitazone).
Rosiglitazone maleate
See Detailed Description.
2
The second group will be given a placebo.
Placebo
See detailed description.
Interventions
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Rosiglitazone maleate
See Detailed Description.
Placebo
See detailed description.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
70 Years
ALL
No
Sponsors
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University of British Columbia
OTHER
Responsible Party
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University of British Columbia
Principal Investigators
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Greg Bondy, MD
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Locations
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St. Paul's Hospital
Vancouver, British Columbia, Canada
Countries
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Related Links
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Related Info
Other Identifiers
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CTN 178
Identifier Type: -
Identifier Source: secondary_id
P02-0086
Identifier Type: -
Identifier Source: org_study_id