Switch to Atazanavir and Brachial Artery Reactivity (SABAR) Study

NCT ID: NCT00225017

Last Updated: 2012-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2008-06-30

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.

Conditions

HIV Infection; Hyperlipidemia

Keywords

Atazanavir; Endothelial function; Treatment Experienced

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Atazanavir

Intervention Type: DRUG

atazanavir 400 mg once daily

B

ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus \> 2 NRTIs) for 24 weeks

Group Type: ACTIVE_COMPARATOR

current antiretroviral regimen

Intervention Type: DRUG

Continue current antiretroviral regimen for 24 weeks, single or RTV-boosted PI plus \> 2 NRTIs

Interventions

Atazanavir

atazanavir 400 mg once daily

Intervention Type: DRUG

current antiretroviral regimen

Continue current antiretroviral regimen for 24 weeks, single or RTV-boosted PI plus \> 2 NRTIs

Intervention Type: DRUG

Other Intervention Names

Reyataz

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Robert L. Murphy

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert L Murphy, MD

Role: STUDY_CHAIR

Northwestern University

James H Stein, MD

Role: STUDY_CHAIR

University of Wisconsin, Madison

Locations

University of California

San Diego, California, United States

Northwestern Universtiy

Chicago, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

University of Cincinnati

Cincinnati, Ohio, United States

University of Wisconsin

Madison, Wisconsin, United States

ACLIRES - Argentina S.R.L.

Buenos Aires, , Argentina

Universita degli studi di Modena e Reggio Emilia

Modena, , Italy

Countries

United States; Argentina; Italy

References

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.

Reference Type: RESULT

PMID: 19952712 (View on PubMed)

Other Identifiers

SABAR

Identifier Type: -

Identifier Source: org_study_id