Switch to Atazanavir and Brachial Artery Reactivity (SABAR) Study (SABAR)
HIV Infection, Hyperlipidemia
About this trial
This is an interventional treatment trial for HIV Infection focused on measuring Atazanavir, Endothelial function, Treatment Experienced
Eligibility 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
Sites / Locations
- University of California
- Northwestern Universtiy
- Indiana University
- University of Cincinnati
- University of Wisconsin
- ACLIRES - Argentina S.R.L.
- Universita degli studi di Modena e Reggio Emilia
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
A
B
ARM A: Switch current PI to atazanavir 400 mg once daily plus current > 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) for 24 weeks. Subjects currently on ritonavir (RTV) (400 mg BID or greater) or RTV-boosted PI (<400 mg/day) , or tenofovir (TDF) as backbone NRTI therapy, will switch to ATV 300 mg boosted with RTV 100mg once daily.
ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus > 2 NRTIs) for 24 weeks