Switch to Atazanavir and Brachial Artery Reactivity (SABAR) Study

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Robert L. Murphy, Northwestern University
ClinicalTrials.gov Identifier:
NCT00225017
First received: September 21, 2005
Last updated: June 29, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention Phase
HIV Infection
Hyperlipidemia
Drug: Atazanavir
Drug: current antiretroviral regimen
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Switch to Atazanavir and Brachial Artery Reactivity (SABAR) Study: Endothelial Function in HIV-Infected Subjects Switched to an Atazanavir Regimen

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Percentage Change in Brachial Artery Flow Mediated (FMD) Vasodilation Between Arms From Baseline to Week 24 [ Time Frame: Baseline to week 24 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Change in Total Cholesterol Levels From Baseline to Week 24 [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: No ]
    Total cholesterol level changes within and between arms

  • Changes in LDL Particle Number From Baseline to Week 24 [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: No ]
    Change in LDL particle number


Enrollment: 50
Study Start Date: June 2005
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A

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.

Drug: Atazanavir
atazanavir 400 mg once daily
Other Name: Reyataz
Active Comparator: B
ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus > 2 NRTIs) for 24 weeks
Drug: current antiretroviral regimen
Continue current antiretroviral regimen for 24 weeks, single or RTV-boosted PI plus > 2 NRTIs

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00225017

Locations
United States, California
University of California
San Diego, California, United States, 92103
United States, Illinois
Northwestern Universtiy
Chicago, Illinois, United States, 60611
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Argentina
ACLIRES - Argentina S.R.L.
Buenos Aires, Argentina
Italy
Universita degli studi di Modena e Reggio Emilia
Modena, Italy
Sponsors and Collaborators
Northwestern University
Bristol-Myers Squibb
Investigators
Study Chair: Robert L Murphy, MD Northwestern University
Study Chair: James H Stein, MD University of Wisconsin, Madison
  More Information

Publications:
Responsible Party: Robert L. Murphy, Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT00225017     History of Changes
Other Study ID Numbers: SABAR
Study First Received: September 21, 2005
Results First Received: October 4, 2010
Last Updated: June 29, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Northwestern University:
Atazanavir
Endothelial function
Treatment Experienced

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Hyperlipidemias
Dyslipidemias
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Lipid Metabolism Disorders
Metabolic Diseases
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Atazanavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014