Status:
COMPLETED
Rosiglitazone (Avandia®) Treatment in HIV: Its Effect on Blood Vessels
Lead Sponsor:
University of British Columbia
Conditions:
Atherosclerosis
HIV Infections
Eligibility:
All Genders
30-70 years
Phase:
NA
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 e...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00143624
Start Date
June 1 2003
End Date
December 1 2009
Last Update
December 9 2009
Active Locations (1)
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1
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6