Switch to Atazanavir and Brachial Artery Reactivity (SABAR) Study

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

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 regimen

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Collaborator: Bristol-Myers Squibb
• Treatments: Anti-Retroviral Agents; Atazanavir Sulfate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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