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Switch to Atazanavir and Brachial Artery Reactivity (SABAR) Study (SABAR)

Primary Purpose

HIV Infection, Hyperlipidemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Atazanavir
current antiretroviral regimen
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infection focused on measuring Atazanavir, Endothelial function, Treatment Experienced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Total Cholesterol Levels From Baseline to Week 24
Total cholesterol level changes within and between arms
Changes in LDL Particle Number From Baseline to Week 24
Change in LDL particle number

Full Information

First Posted
September 21, 2005
Last Updated
June 29, 2012
Sponsor
Northwestern University
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00225017
Brief Title
Switch to Atazanavir and Brachial Artery Reactivity (SABAR) Study
Acronym
SABAR
Official Title
Switch to Atazanavir and Brachial Artery Reactivity (SABAR) Study: Endothelial Function in HIV-Infected Subjects Switched to an Atazanavir Regimen
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection, Hyperlipidemia
Keywords
Atazanavir, Endothelial function, Treatment Experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
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 Title
B
Arm Type
Active Comparator
Arm Description
ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus > 2 NRTIs) for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Atazanavir
Other Intervention Name(s)
Reyataz
Intervention Description
atazanavir 400 mg once daily
Intervention Type
Drug
Intervention Name(s)
current antiretroviral regimen
Intervention Description
Continue current antiretroviral regimen for 24 weeks, single or RTV-boosted PI plus > 2 NRTIs
Primary Outcome Measure Information:
Title
Percentage Change in Brachial Artery Flow Mediated (FMD) Vasodilation Between Arms From Baseline to Week 24
Description
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
Time Frame
Baseline to week 24
Secondary Outcome Measure Information:
Title
Change in Total Cholesterol Levels From Baseline to Week 24
Description
Total cholesterol level changes within and between arms
Time Frame
Baseline to 24 weeks
Title
Changes in LDL Particle Number From Baseline to Week 24
Description
Change in LDL particle number
Time Frame
Baseline to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert L Murphy, MD
Organizational Affiliation
Northwestern University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
James H Stein, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Study Chair
Facility Information:
Facility Name
University of California
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Northwestern Universtiy
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
ACLIRES - Argentina S.R.L.
City
Buenos Aires
Country
Argentina
Facility Name
Universita degli studi di Modena e Reggio Emilia
City
Modena
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
19952712
Citation
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.
Results Reference
result

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