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Switch to Atazanavir and Brachial Artery Reactivity (SABAR) Study

Information source: Northwestern University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infection; Hyperlipidemia

Intervention: Atazanavir (Drug); current antiretroviral regimen (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Northwestern University

Official(s) and/or principal investigator(s):
Robert L Murphy, MD, Study Chair, Affiliation: Northwestern University
James H Stein, MD, Study Chair, Affiliation: University of Wisconsin, Madison


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

Clinical Details

Official title: Switch to Atazanavir and Brachial Artery Reactivity (SABAR) Study: Endothelial Function in HIV-Infected Subjects Switched to an Atazanavir Regimen

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage Change in Brachial Artery Flow Mediated (FMD) Vasodilation Between Arms From Baseline to Week 24

Secondary outcome:

Change in Total Cholesterol Levels From Baseline to Week 24

Changes in LDL Particle Number From Baseline to Week 24

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 levels >200 mg/dL, will be randomized (1: 1) to continue their current antiretroviral regimen or to switch the PI to atazanavir (ATV). Brachial artery reactivity will be measured before (at entry) and 12 and 24 weeks after subjects are randomized. 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 Brachial artery reactivity in response to two vasoactive stimuli (increased forearm blood flow and nitroglycerin) will be assessed by measuring brachial artery diameter.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

ACLIRES - Argentina S.R.L., Buenos Aires, Argentina

Universita degli studi di Modena e Reggio Emilia, Modena, Italy

University of California, San Diego, California 92103, United States

Northwestern Universtiy, Chicago, Illinois 60611, United States

Indiana University, Indianapolis, Indiana 46202, United States

University of Cincinnati, Cincinnati, Ohio 45267, United States

University of Wisconsin, Madison, Wisconsin 53792, United States

Additional Information

Starting date: June 2005
Last updated: June 29, 2012

Page last updated: August 23, 2015

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