drugset / Trial / NCT00994344

Clinical Study to Evaluate the Efficacy and Safety of Lopinavir/Ritonavir Monotherapy Versus Darunavir/Ritonavir Monotherapies as Simplification Switching Strategies of PI/NNRTI-Triple Therapy Based-Regimens

NCT00994344

Phase 4 Completed 73 enrolled Germans Trias i Pujol Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the non-inferiority in the efficacy of DRV/r (900/100 mg) monotherapy at 48 weeks versus LPV/r (400/100 mg) as simplification strategy in subjects with sustained viral suppression on stable PI or NNRTI-antiretroviral regimens.

Timeline

Start
2009-10
Primary completion
2012-10
Completion
2012-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Darunavir Small molecule 800 mg
Comparator Lopinavir Other / unclassified 400 mg
Background Ritonavir Other / unclassified 100 mg