drugset / Trial / NCT05006170

Pharmacokinetics, Safety, and Efficacy of Dolutegravir Dispersible Tablets in Young Children Living With HIV

NCT05006170

Phase 2 Unknown 30 enrolled Chulalongkorn University
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate steady-state pharmacokinetics of DTG dispersible tablets in children with HIV infection weighing from 6 to below 20 kg and to determine the dose of DTG that achieves adult target PK parameter(trough concentration; AUC24h)

Timeline

Start
2021-08-03
Primary completion
2022-02-28
Completion
2022-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Dolutegravir Other / unclassified 20 mg Oral
Subject Dolutegravir Other / unclassified 25 mg Oral