Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00225017
Status:
COMPLETED
Last Update Posted:
2012-08-02
First Post:
2005-09-21
Brief Title:
Switch to Atazanavir and Brachial Artery Reactivity SABAR Study
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Switch to Atazanavir and Brachial Artery Reactivity SABAR Study Endothelial Function in HIV-Infected Subjects Switched to an Atazanavir Regimen
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SABAR
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 copiesmL who have LDL cholesterol levels 130 mgdL or fasting triglycerides levels 200 mgdL will be randomized 11 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 nucleosidenucleotide reverse transcriptase inhibitors NRTIs for 24 weeks
Subjects currently on ritonavir RTV 400 mg BID or greater or RTV-boosted PI 400 mgday 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
ARM A Switch current PI to atazanavir 400 mg once daily plus current 2 nucleosidenucleotide reverse transcriptase inhibitors NRTIs for 24 weeks
Subjects currently on ritonavir RTV 400 mg BID or greater or RTV-boosted PI 400 mgday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None