TMC125-TiDP35-C213: Safety and Antiviral Activity of Etravirine (TMC125) in Treatment-Experienced, HIV Infected Children and Adolescents

Phase 2 Completed 103 enrolled Tibotec Pharmaceuticals, Ireland

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the safety and antiviral activity of etravirine in treatment-experienced human immunodeficiency virus (HIV) infected children and adolescents.

Timeline

Start: 2008-11
Primary completion: 2011-05
Completion: 2011-08

Publications

Tambuyzer L, Thys K, Hoogstoel A, Nijs S, Tomaka F, Opsomer M, De Meyer S, Vingerhoets J. Assessment of etravirine resistance in HIV-1-infected paediatric patients using population and deep sequencing: final results of the PIANO study. Antivir Ther. 2016;21(4):317-27. doi: 10.3851/IMP3011. Epub 2015 Nov 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Etravirine	Small molecule	5.2 mg/kg	—
Background	Atazanavir	Other / unclassified	—	—
Background	Darunavir	Small molecule	—	—
Background	Lopinavir	Other / unclassified	—	—
Background	Ritonavir	Other / unclassified	—	—
Background	Saquinavir	Small molecule	—	—

Indications

No indication recorded.