NCT05006170

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Chulalongkorn University · Academic / Other
• Sex: All
• Age: 3 Months – 7 Years
• Healthy volunteers: Not accepted

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)

Detailed description

After being informed about the study and potential risks, all legal guardians giving written informed consent will undergo check eligibility to enroll the study entry. Patients will be sort into 3 weight band groups 6 to below 10 kg, 10 to below 14 kg, and 14 to below 20 kg. ARTs will be switched to DTG dispersible tablet and ABC/3TC once daily will be prescribed according to weight band dosage. Total of 7 time point of blood sampling for plasma DTG concentrations will be measure at 7-14 day after medication switch. Patient will be follow up as schedule for total 24 week to assess safety, and efficacy of DTG dispersible tablet combine with ABC/3TC.

Conditions

• Pediatric HIV Infection

Interventions

Type	Name	Description
DRUG	DTG DT 20 mg	Give 2 tabs of MYLTEGA DT (10mg) PO once daily
DRUG	DTG DT 25 mg	Give 2.5 tabs of MYLTEGA DT (10mg) PO once daily

Timeline

• Start date: 2021-08-03
• Primary completion: 2022-02-28
• Completion: 2022-06-30
• First posted: 2021-08-16
• Last updated: 2021-11-23

Locations

1 site across 1 country: Thailand