Switch to Atazanavir and Brachial Artery Reactivity (SABAR) Study

HIV Infection Clinical Trial

— SABAR  

Official title:

Switch to Atazanavir and Brachial Artery Reactivity (SABAR) Study: Endothelial Function in HIV-Infected Subjects Switched to an Atazanavir Regimen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00225017
• Other study ID #: SABAR
• Status: Completed
• Phase: Phase 3
• First received: September 21, 2005
• Last updated: June 29, 2012
• Start date: June 2005
• Est. completion date: June 2008

Study information

• Verified date: June 2012
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infection
• Hyperlipidemia
• Hyperlipidemias

Intervention

Drug:
• Atazanavir
atazanavir 400 mg once daily
• current antiretroviral regimen
Continue current antiretroviral regimen for 24 weeks, single or RTV-boosted PI plus > 2 NRTIs

Locations

Country	Name	City	State
Argentina	ACLIRES - Argentina S.R.L.	Buenos Aires
Italy	Universita degli studi di Modena e Reggio Emilia	Modena
United States	Northwestern Universtiy	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	Indiana University	Indianapolis	Indiana
United States	University of Wisconsin	Madison	Wisconsin
United States	University of California	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Italy, 

References & Publications (1)

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 ther — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in Total Cholesterol Levels From Baseline to Week 24	Total cholesterol level changes within and between arms	Baseline to 24 weeks	No
Secondary	Changes in LDL Particle Number From Baseline to Week 24	Change in LDL particle number	Baseline to 24 weeks	No