CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 50 enrolled
Drug / intervention
Atazanavir +1 moredrug
Likely dose
Atazanavir 400 mg once dailyAI-extracted
Key inclusion· 4
  • ✓HIV-1 RNA <500 copies/mL (virally suppressed)
  • ✓CD4 count >100 cells/mm³
  • ✓Fasting LDL cholesterol >130 mg/dL OR fasting triglycerides >200 mg/dL
  • ✓Stable antiretroviral regimen for ≥12 weeks prior to entry with a protease inhibitor (±ritonavir boosting)
Key exclusion· 4
  • ✕History of heart disease, uncontrolled hypertension, or peripheral vascular disease
  • ✕Current NNRTI in the PI-containing regimen within 4 weeks
  • ✕Prior or current use of atazanavir
  • ✕Initiation of lipid-lowering drugs within 4 weeks prior to study entry

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00225017
NCT00225017Phase 3Completed
CompareCT.gov

Switch to Atazanavir and Brachial Artery Reactivity (SABAR) Study: Endothelial Function in HIV-Infected Subjects Switched to an Atazanavir Regimen

Northwestern University·interventional·Posted Sep 23, 2005·Updated Aug 2, 2012

In Brief

A Phase 3 clinical trial evaluating Atazanavir and current antiretroviral regimen for HIV Infection and Hyperlipidemia. Completed, enrolled 50 participants across 7 sites in 3 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infection, Hyperlipidemia
CountriesArgentina, Italy, United States
CollaboratorsBristol-Myers Squibb

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 23, 2005
Enrollment StartJun 1, 2005
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 20.8 years ago

Interventions

Atazanavirdrug

atazanavir 400 mg once daily

current antiretroviral regimendrug

Continue current antiretroviral regimen for 24 weeks, single or RTV-boosted PI plus \> 2 NRTIs