Switch to Atazanavir and Brachial Artery Reactivity (SABAR) Study

Northwestern University

Status and phase: Completed; Phase 3

Conditions: Hyperlipidemia; HIV Infection

Treatments: Drug: current antiretroviral regimen; Drug: Atazanavir

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00225017

SABAR

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

A

Experimental group

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.

Treatment:

Drug: Atazanavir

B

Active Comparator group

Description:

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

Treatment:

Drug: current antiretroviral regimen