A Phase 2 Study to Evaluate Pharmacokinetics, Safety and Efficacy of TMC114/Ritonavir (Rtv) in Human Immunodeficiency Virus (HIV)-1 Infected Children and Adolescents

Phase 2 Completed 80 enrolled Tibotec Pharmaceuticals, Ireland

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time), safety, tolerability and antiviral activity to support dose recommendations of TMC114 with ritonavir and other antiretroviral agents in treatment-experienced, human immunodeficiency virus (HIV)-1 infected children and adolescents.

Timeline

Start: 2006-06
Primary completion: 2007-08
Completion: 2011-03

Publications

Results Blanche S, Bologna R, Cahn P, Rugina S, Flynn P, Fortuny C, Vis P, Sekar V, van Baelen B, Dierynck I, Spinosa-Guzman S. Pharmacokinetics, safety and efficacy of darunavir/ritonavir in treatment-experienced children and adolescents. AIDS. 2009 Sep 24;23(15):2005-13. doi: 10.1097/QAD.0b013e328330abaa.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Darunavir	Small molecule	300 mg	Oral
Subject	Darunavir	Small molecule	375 mg	Oral
Subject	Darunavir	Small molecule	450 mg	Oral
Subject	Darunavir	Small molecule	600 mg	Oral
Subject	Ritonavir	Other / unclassified	50 mg	Oral
Subject	Ritonavir	Other / unclassified	60 mg	Oral
Subject	Ritonavir	Other / unclassified	100 mg	Oral

A Phase 2 Study to Evaluate Pharmacokinetics, Safety and Efficacy of TMC114/Ritonavir (Rtv) in Human Immunodeficiency Virus (HIV)-1 Infected Children and Adolescents

Summary

Timeline

Publications

Drugs

Indications