drugset / Trial / NCT00111280
TMC125-C211: Trial of TMC125 in HIV-1 Infected Subjects Who Were in a Sponsor Selected TMC125 Trial
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Etravirine | Small molecule | 200 mg | — |
| Subject | Etravirine | Small molecule | 800 mg | — |