A Safety Study to Evaluate the Antiviral Activity of Darunavir in Combination With Ritonavir in HIV 1 Infected Children

NCT00919854 ↗

Phase 2 Completed 27 enrolled Tibotec Pharmaceuticals, Ireland Tibotec Pharmaceutical Limited · collab

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the pharmacokinetics (what the body does to the medication), safety and antiviral activity to support dose recommendations by body weight of darunavir with low-dose ritonavir (DRV/rtv), in combination with other antiretroviral drugs (ARVs), in treatment-experienced Human immunodeficiency virus 1 (HIV 1) infected children.

Timeline

Start: 2009-09
Primary completion: 2010-08
Completion: 2011-02

Publications

Violari A, Bologna R, Kumarasamy N, Pilotto JH, Hendrickx A, Kakuda TN, Lathouwers E, Opsomer M, Van de Casteele T, Tomaka FL. Safety and efficacy of darunavir/ritonavir in treatment-experienced pediatric patients: week 48 results of the ARIEL trial. Pediatr Infect Dis J. 2015 May;34(5):e132-7. doi: 10.1097/INF.0000000000000644.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Darunavir	Small molecule	25 mg/kg	Oral
Subject	Darunavir	Small molecule	375 mg	Oral
Subject	Ritonavir	Other / unclassified	3 mg/kg	Oral
Subject	Ritonavir	Other / unclassified	50 mg	Oral

A Safety Study to Evaluate the Antiviral Activity of Darunavir in Combination With Ritonavir in HIV 1 Infected Children

Summary

Timeline

Publications

Drugs

Indications