HIV Infection Clinical Trial
Official title:
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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