drugset / Trial / NCT00458302

Treatment Simplification by Darunavir/Ritonavir 800/100 mg Once a Day Versus a Triple Combination Therapy With Darunavir/Ritonavir

NCT00458302

Phase 3 Completed 256 enrolled Janssen-Cilag International NV
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the study is to compare the efficacy, safety and tolerability of darunavir/ritonavir 800/100 mg once a day (O.D.) as a monotherapy versus a triple combination therapy containing 2 nucleosides and darunavir/ritonavir in 250 HIV-1 infected patients who have been on Highly Active Antiretroviral Therapy (HAART) and have plasma viral load below 50 copies/ml for at least 24 weeks.

Timeline

Start
2007-06
Primary completion
2009-02
Completion
2011-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Darunavir Small molecule 800 mg Oral