NCT00225017|CompletedPhase 3ResultsDMC
Switch to Atazanavir and Brachial Artery Reactivity (SABAR) Study
SABAR
Loading search results
Sponsor study identifier
interventional
50
3 countries
7
Study Start
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2008
Actual (reported)Study Completion
June 2008
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
September 21, 2005
Actual (reported)September 23, 2005
Actual (reported)June 2008
Actual (reported)June 2008
Actual (reported)August 2, 2012
Actual (reported)Percentage Change in Brachial Artery Flow Mediated (FMD) Vasodilation Between Arms From Baseline to Week 24
Brachial artery reactivity assessed by noninvasively measuring brachial artery diameter and flow velocities in response to overinflated blood pressure cuff (Flow mediated dilation (FMD))in subjects switching to atazanavir and in subjects continuing on a stable antiretroviral regimen
Baseline to week 24
Change in Total Cholesterol Levels From Baseline to Week 24
Baseline to 24 weeks
Changes in LDL Particle Number From Baseline to Week 24
Baseline to 24 weeks
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
atazanavir 400 mg once daily
Continue current antiretroviral regimen for 24 weeks, single or RTV-boosted PI plus \> 2 NRTIs
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
ACLIRES - Argentina S.R.L.
Buenos Aires, Argentina
Universita degli studi di Modena e Reggio Emilia
Modena, Italy
Murphy RL, Berzins B, Zala C, Fichtenbaum C, Dube MP, Guaraldi G, Torriani F, Belsey E, Mitchell C, Stein JH; SABAR Study Team. Change to atazanavir/ritonavir treatment improves lipids but not endothelial function in patients on stable antiretroviral therapy. AIDS. 2010 Mar 27;24(6):885-90. doi: 10.1097/QAD.0b013e3283352ed5.
Robert L Murphy, MD
Northwestern University
James H Stein, MD
University of Wisconsin, Madison
50 participants (actual enrollment reported by the registry).
First Submitted
September 21, 2005
First Posted
September 23, 2005
Study Start
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
June 2008
Actual (reported)Study Completion
June 2008
Actual (reported)Last Updated
August 2, 2012
Results First Posted
August 2, 2012
Record last verified: 2012-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: