drugset / Trial / NCT00531323

TMC 125 Blood Levels Study

NCT00531323

Phase 1 Completed 24 enrolled St Stephens Aids Trust
RandomizedParallel-groupOpen-label

Summary

The purpose of the study is to look at whether changing directly from one medication for HIV (efavirenz) to a new medication for HIV (TMC125) has any effect on the levels of TMC125 in the blood, compared to when TMC125 is taken without efavirenz having been taken immediately beforehand. The study aims to help the investigators understand whether it is safe to change directly from efavirenz to TMC125 (with no gap between the treatments) in patients who need these treatments. The study will investigate the blood levels of TMC125 when it is taken both once and twice a day.

Timeline

Start
2007-09
Primary completion
Completion
2007-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Etravirine Small molecule 200 mg
Subject Etravirine Small molecule 400 mg