A Study to Compare Effectiveness and Safety of Darunavir/Ritonavir (DRV/Rtv) 800mg/100mg Once Daily Versus DRV/Rtv 600mg/100mg Twice Daily in Early Treatment-Experienced HIV-1 Infected Patients (ODIN)

Summary

The purpose of this study is to test if being treated with darunavir/ritonavir (DRV/rtv) 800/100 mg daily is as effective as being treated with DRV/rtv 600/100 mg twice daily, in early antiretroviral (ARV)-experienced patients when given along with selected optimized background regimen (OBR).

Timeline

Start

2007-10

Primary completion

2009-08

Completion

2011-10

Outcome

Met primary endpoint

paper which demonstrated non-inferiority of once-daily darunavir/ritonavir (DRV/r) 800/100 mg to DRV/r 600/100 mg twice daily PMID 23558157 ↗

registry analysis (non-inferiority or equivalence test); DRV/Rtv 800/100 mg Once Daily vs DRV/Rtv 600/100 mg Twice Daily; p <0.001 NCT00524368 ↗

Publications

• Lathouwers E, De La Rosa G, Van de Casteele T, Baeten B, Tomaka F, De Meyer S, Picchio G. Virological analysis of once-daily and twice-daily darunavir/ritonavir in the ODIN trial of treatment-experienced patients. Antivir Ther. 2013;18(3):289-300. doi: 10.3851/IMP2569. Epub 2013 Apr 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Darunavir	Small molecule	600 mg	Oral
Subject	Darunavir	Small molecule	800 mg	Oral
Subject	Ritonavir	Other / unclassified	100 mg	Oral

Indications