Phase 3
Completed N=50
Switch to Atazanavir and Brachial Artery Reactivity (SABAR) Study
Source: ClinicalTrials.gov NCT00225017 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcomePrimary: Percentage Change in Brachial Artery Flow Mediated (FMD) Vasodilation Between Arms From Baseline to Week 24 — -1.14; 0.25 percentage change — p=0.601
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change in Brachial Artery Flow Mediated (FMD) Vasodilation Between Arms From Baseline to Week 24 |
-1.14; 0.25 | 0.601 |
| SECONDARY Change in Total Cholesterol Levels From Baseline to Week 24 |
-25; 2 | <0.009 sig |
| SECONDARY Changes in LDL Particle Number From Baseline to Week 24 |
-194; -116 | 0.141 |
Eligibility Criteria
Inclusion Criteria
- HIV infection
- HIV-1 RNA 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
Data sourced from ClinicalTrials.gov (NCT00225017). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.