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Week 48 analysis of once-daily vs. twice-daily darunavir/ritonavir in treatment-experienced HIV-1-infected patients

Week 48 analysis of once-daily vs. twice-daily darunavir/ritonavir in treatment-experienced... Week 48 analysis of once-daily vs. twice-daily darunavir/ritonavir in treatment-experienced HIV-1-infected patients a b c d Pedro Cahn , Jan Fourie , Beatriz Grinsztejn , Sally Hodder , e f g Jean-Michel Molina , Kiat Ruxrungtham , Cassy Workman , h h h Tom Van De Casteele , Piet De Doncker , Erkki Lathouwers and Frank Tomaka Objective: ODIN (Once-daily Darunavir In treatment-experieNced patients) was a phase III, 48-week, open-label study comparing once-daily vs. twice-daily darunavir/ ritonavir (DRV/r) in treatment-experienced patients with no DRV resistance-associated mutations (RAMs) at screening. Methods: Patients with no DRV RAMs and receiving stable HAART for at least 12 weeks were stratified by HIV-1 RNA ( or> 50 000 copies/ml) and randomized to once-daily DRV/r 800/100 mg or twice-daily DRV/r 600/100 mg and an optimized background regimen (2 nucleoside reverse transcriptase inhibitors). Primary objective was to demonstrate noninferiority of once-daily vs. twice-daily DRV/r in confirmed virologic response (HIV-1 RNA< 50 copies/ml) at week 48. Results: Five hundred and ninety patients received once-daily (n¼ 294) or twice-daily (n¼ 296) DRV/r. Mean baseline HIV-1 RNA was 4.16 log copies/ml; median CD4 cell count was 228 cells/ml; and 53.9% had previously used at least one protease inhibitor. At http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png AIDS Wolters Kluwer Health

Week 48 analysis of once-daily vs. twice-daily darunavir/ritonavir in treatment-experienced HIV-1-infected patients

AIDS , Volume 25 (7) – Apr 1, 2011

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References (26)

ISSN
0269-9370
eISSN
1473-5571
DOI
10.1097/QAD.0b013e328345ee95
pmid
21346512
Publisher site
See Article on Publisher Site

Abstract

Week 48 analysis of once-daily vs. twice-daily darunavir/ritonavir in treatment-experienced HIV-1-infected patients a b c d Pedro Cahn , Jan Fourie , Beatriz Grinsztejn , Sally Hodder , e f g Jean-Michel Molina , Kiat Ruxrungtham , Cassy Workman , h h h Tom Van De Casteele , Piet De Doncker , Erkki Lathouwers and Frank Tomaka Objective: ODIN (Once-daily Darunavir In treatment-experieNced patients) was a phase III, 48-week, open-label study comparing once-daily vs. twice-daily darunavir/ ritonavir (DRV/r) in treatment-experienced patients with no DRV resistance-associated mutations (RAMs) at screening. Methods: Patients with no DRV RAMs and receiving stable HAART for at least 12 weeks were stratified by HIV-1 RNA ( or> 50 000 copies/ml) and randomized to once-daily DRV/r 800/100 mg or twice-daily DRV/r 600/100 mg and an optimized background regimen (2 nucleoside reverse transcriptase inhibitors). Primary objective was to demonstrate noninferiority of once-daily vs. twice-daily DRV/r in confirmed virologic response (HIV-1 RNA< 50 copies/ml) at week 48. Results: Five hundred and ninety patients received once-daily (n¼ 294) or twice-daily (n¼ 296) DRV/r. Mean baseline HIV-1 RNA was 4.16 log copies/ml; median CD4 cell count was 228 cells/ml; and 53.9% had previously used at least one protease inhibitor. At

Journal

AIDSWolters Kluwer Health

Published: Apr 1, 2011

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