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
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
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 24Changes 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
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
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