A Study to Evaluate the Pharmacokinetic Profile (How the Body Absorbs, Distributes, Metabolizes and Eliminates a Drug) of TMC125 Plus Tenofovir/Emtricitabine Once Daily With or Without Darunavir/r Once Daily in Antiretroviral (ARV) Naive HIV-1 Patients (Patients Have Never Received ARV Treatment).

Phase 2 Completed 23 enrolled Tibotec, Inc Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the pharmacokinetic profile of TMC125 400mg with tenofovir DF/emtricitabine FDC (fixed dose combination) 300/200mg all dosed once daily with and without darunavir/ritonavir 800/100 mg once daily in HIV-1 infected, antiretroviral (ARV) naÃ-ve patients (patients who have never received ARV treatment).

Timeline

Start: 2008-01
Primary completion: 2008-05
Completion: 2009-03

Publications

DeJesus E, Lalezari JP, Osiyemi OO, Ruane PJ, Ryan R, Kakuda TN, Witek J. Pharmacokinetics of once-daily etravirine without and with once-daily darunavir/ritonavir in antiretroviral-naive HIV type-1-infected adults. Antivir Ther. 2010;15(5):711-20. doi: 10.3851/IMP1562.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Darunavir	Small molecule	800 mg	Oral
Subject	Etravirine	Small molecule	400 mg	Oral
Subject	Ritonavir	Other / unclassified	100 mg	Oral

A Study to Evaluate the Pharmacokinetic Profile (How the Body Absorbs, Distributes, Metabolizes and Eliminates a Drug) of TMC125 Plus Tenofovir/Emtricitabine Once Daily With or Without Darunavir/r Once Daily in Antiretroviral (ARV) Naive HIV-1 Patients (Patients Have Never Received ARV Treatment).

Summary

Timeline

Publications

Drugs

Indications