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

September 21, 2005
June 29, 2012
June 2005
June 2008   (final data collection date for primary outcome measure)
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
To compare the change in brachial artery flow mediated (FMD) vasodilation from baseline to week 24 in subjects switching to atazanavir with the change in FMD in subjects continuing on a stable antiretroviral regimen
Complete list of historical versions of study NCT00225017 on ClinicalTrials.gov Archive Site
  • 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
  • To compare the changes in LDL particle number, diameter, insulin sensitivity from baseline to week 24 between arms.
  • To evaluate change in FMD from baseline to week 24 within each arm.
  • To evaluate lipid levels and to relate their changes to FMD and changes in FMD both within and between arms
Not Provided
Not Provided
 
Switch to Atazanavir and Brachial Artery Reactivity (SABAR) Study
Switch to Atazanavir and Brachial Artery Reactivity (SABAR) Study: Endothelial Function in HIV-Infected Subjects Switched to an Atazanavir Regimen

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infection
  • Hyperlipidemia
  • Drug: Atazanavir
    atazanavir 400 mg once daily
    Other Name: Reyataz
  • Drug: current antiretroviral regimen
    Continue current antiretroviral regimen for 24 weeks, single or RTV-boosted PI plus > 2 NRTIs
  • 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.

    Intervention: Drug: Atazanavir
  • Active Comparator: B
    ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus > 2 NRTIs) for 24 weeks
    Intervention: Drug: current antiretroviral regimen
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   United States,   Italy
 
NCT00225017
SABAR
Yes
Robert L. Murphy, Northwestern University
Northwestern University
Bristol-Myers Squibb
Study Chair: Robert L Murphy, MD Northwestern University
Study Chair: James H Stein, MD University of Wisconsin, Madison
Northwestern University
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP