drugset / Trial / NCT00111280

TMC125-C211: Trial of TMC125 in HIV-1 Infected Subjects Who Were in a Sponsor Selected TMC125 Trial

NCT00111280

Phase 2 Completed 48 enrolled Tibotec Pharmaceuticals, Ireland
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a Phase II, open-label, roll-over trial to evaluate the long term safety and tolerability of TMC125, administered as part of an individually optimized antiretroviral therapy, in HIV 1 infected subjects. In addition, the antiviral activity and immunological effect of TMC125 as part of an antiretroviral regimen over time, and the evolution of HIV phenotype and genotype will be evaluated.

Timeline

Start
2004-09
Primary completion
Completion
2007-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Etravirine Small molecule 200 mg
Subject Etravirine Small molecule 800 mg