TMC114-TiDP29-C232 - Study Providing Continued Access to Treatment With Darunavir (DRV)/Ritonavir (Rtv) for Children Coming From Any of the Three Ongoing Tibotec Sponsored Pediatric Studies With DRV

Phase 2 Completed 46 enrolled Janssen Sciences Ireland UC

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of this study is to continue to provide Darunavir (DRV) to pediatric patients who previously received DRV in any of three pediatric clinical studies sponsored by Tibotec Pharmaceuticals and continue to benefit from using it, in countries where DRV is not yet commercially available for the pediatric patient, is not reimbursed or cannot be accessed through another source (like access program or government program).

Timeline

Start: 2010-10-13
Primary completion: 2017-11-23
Completion: 2017-11-23

Publications

Violari A, Masenya M, Blanche S, Vanveggel S, Hufkens V, Chetty P, Opsomer M. The DIANA Study: Continued Access to Darunavir/Ritonavir (DRV/r) and Long-Term Safety Follow-Up in HIV-1-Infected Pediatric Patients Aged 3 to < 18 Years. Drug Saf. 2021 Apr;44(4):439-446. doi: 10.1007/s40264-020-01032-0. Epub 2020 Dec 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Darunavir	Small molecule	20 mg/kg	Oral
Subject	Darunavir	Small molecule	375 mg	Oral
Subject	Darunavir	Small molecule	450 mg	Oral
Subject	Darunavir	Small molecule	600 mg	Oral
Subject	Darunavir	Small molecule	800 mg	Oral
Subject	Ritonavir	Other / unclassified	10 mg/ml	Oral
Subject	Ritonavir	Other / unclassified	80 mg/ml	Oral
Subject	Ritonavir	Other / unclassified	100 mg	Oral

TMC114-TiDP29-C232 - Study Providing Continued Access to Treatment With Darunavir (DRV)/Ritonavir (Rtv) for Children Coming From Any of the Three Ongoing Tibotec Sponsored Pediatric Studies With DRV

Summary

Timeline

Publications

Drugs

Indications