Status:
COMPLETED
Switch to Atazanavir and Brachial Artery Reactivity (SABAR) Study
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
HIV Infection
Hyperlipidemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the change in brachial artery reactivity in HIV-infected subjects with elevated lipid levels who are switched to an atazanavir containing antiretroviral regime...
Detailed Description
HIV-infected subjects on a stable protease inhibitor (PI) containing antiretroviral regimen with plasma HIV RNA \<500 copies/mL, who have LDL cholesterol levels \>130 mg/dL or fasting triglycerides le...
Eligibility Criteria
Inclusion
- HIV infection
- HIV-1 RNA \< 500 copies/ml
- Fasting LDL cholesterol \>130 mg/dl OR fasting triglycerides \>200 mg/dl
- CD4 count \>100 cells/mm
- Stable antiretroviral regimen for at least 12 weeks prior to study entry that includes a protease inhibitor (PI) with or without ritonavir boosting
Exclusion
- History of heart disease, uncontrolled hypertension, peripheral vascular disease
- Current non-nucleoside reverse transcriptase inhibitor (NNRTI) in the PI-containing regimen within 4 weeks
- Prior or current use of atazanavir
- Initiation of treatment with lipid-lowering drugs within 4 weeks prior to study entry
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00225017
Start Date
June 1 2005
End Date
June 1 2008
Last Update
August 2 2012
Active Locations (7)
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1
University of California
San Diego, California, United States, 92103
2
Northwestern Universtiy
Chicago, Illinois, United States, 60611
3
Indiana University
Indianapolis, Indiana, United States, 46202
4
University of Cincinnati
Cincinnati, Ohio, United States, 45267