Switch to Atazanavir and Brachial Artery Reactivity (SABAR) Study

Study Results

Results available

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Basic Information

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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

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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

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Detailed Description

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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

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HIV Infection Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

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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

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Reyataz

Eligibility Criteria

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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