Clinical trial NCT00225017: Switch to Atazanavir and Brachial Artery Reactivity (SABAR) Study
Official title: Switch to Atazanavir and Brachial Artery Reactivity (SABAR) Study: Endothelial Function in HIV-Infected Subjects Switched to an Atazanavir Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infection
Hyperlipidemia
Keywords: Atazanavir
Endothelial function
Treatment Experienced
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2005-09-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage Change in Brachial Artery Flow Mediated (FMD) Vasodilation Between Arms From Baseline to Week 24
timeFrame: Baseline to week 24
Secondary outcomes:
measure: Change in Total Cholesterol Levels From Baseline to Week 24
timeFrame: Baseline to 24 weeks
measure: Changes in LDL Particle Number From Baseline to Week 24
timeFrame: Baseline to 24 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California
state: California
city: Chicago
country: United States
facility: Northwestern Universtiy
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: ACLIRES - Argentina S.R.L.
city: Modena
country: Italy
facility: Universita degli studi di Modena e Reggio Emilia
Study officials:
affiliation: Northwestern University
name: Robert L Murphy, MD
role: STUDY_CHAIR
affiliation: University of Wisconsin, Madison
name: James H Stein, MD
role: STUDY_CHAIR
References:
citation: 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.