Overview
Pharmacokinetics, Safety, and Efficacy of Dolutegravir Dispersible Tablets in Young Children Living With HIV
Status:
Recruiting
Recruiting
Trial end date:
2022-06-30
2022-06-30
Target enrollment:
0
0
Participant gender:
All
All
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)Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Chulalongkorn University
Criteria
Inclusion Criteria:- Children living with HIV weighing 6 to below 20 kg
- Naïve to integrase inhibitors
Exclusion criteria:
- Currently active opportunistic infection
- Liver dysfunction (SGPT below 100 IU/mL)
- Renal dysfunction (GFR below 60 mL/min)
- Currently using medication that interacts with DTG