drugset / Trial / NCT00524368

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)

NCT00524368

Phase 3 Completed 590 enrolled Tibotec Pharmaceuticals, Ireland
RandomizedParallel-groupOpen-labelTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Darunavir Small molecule 600 mg Oral
Subject Darunavir Small molecule 800 mg Oral
Subject Ritonavir Other / unclassified 100 mg Oral