drugset / Trial / NCT01121809

Plasma and Intracellular Concentrations of Raltegravir and Etravirine Administered Once Daily

NCT01121809

Phase 4 Completed 16 enrolled Hospitales Universitarios Virgen del Rocío
Non-randomizedCrossoverOpen-labelTreatment

Summary

Hypothesis: the intracellular concentrations of raltegravir (RAL) and etravirine (ETV) administrated as 800 and 400 mg once a day, respectively, are similar to those obtained with the standard doses of 400 and 200 mg/12h, respectively. Objective: To analyze the plasma and intracellular concentrations of RAL and ETV administrated as 800 and 400 mg once daily respectively compared with standard doses of 400 and 200 mg/12h, respectively, and if they support its once daily administration.

Timeline

Start
2010-04
Primary completion
2010-10
Completion
2011-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Etravirine Small molecule 200 mg
Subject Etravirine Small molecule 400 mg
Subject Raltegravir Other / unclassified 400 mg
Subject Raltegravir Other / unclassified 800 mg