drugset

drugset / Trial / NCT01656122

Abacavir and Lamivudine PK in Children

NCT01656122 ↗

Phase 2/3 Completed 30 enrolled The HIV Netherlands Australia Thailand Research Collaboration Chulalongkorn University · collab PHPT/AMS Laboratory, Faculty of Associated Medical Sciences, Chiang Mai University · collab Radboud University Medical Center · collab ViiV Healthcare · collab amfAR, The Foundation for AIDS Research · collab

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the pharmacokinetic parameters for ABC and 3TC in HIV-infected children younger than 18 years old with body weight ≥ 14 kgs.

Timeline

Start: 2012-07
Primary completion: 2015-07
Completion: 2015-07

Publications

Results Bunupuradah T, Punyahotra P, Cressey TR, Srimuan A, Thammajaruk N, Sophonphan J, Sriheara C, Burger DM, Puthanakit T, Ananworanich J. Plasma pharmacokinetics of once-daily abacavir- and lamivudine-containing regimens and week 96 efficacy in HIV-infected Thai children. J Virus Erad. 2015 Jul 1;1(3):185-91. doi: 10.1016/S2055-6640(20)30503-3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Abacavir	Other / unclassified	300 mg	—
Subject	Abacavir	Other / unclassified	450 mg	—
Subject	Abacavir	Other / unclassified	600 mg	—
Subject	Lamivudine	Other / unclassified	150 mg	—
Subject	Lamivudine	Other / unclassified	300 mg	—

Indications