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

Phase 2

• Conditions: Pediatric HIV Infection
• Interventions: Drug: DTG DT 20 mg; Drug: DTG DT 25 mg

• Registration Number: NCT05006170
• Lead Sponsor: Chulalongkorn University

Brief 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.

Study Timeline

• Status Verified: 2021-07
• Study Start: 2021-08-03
• Study First Submitted: 2021-08-04
• Study First Submitted QC: 2021-08-07
• Study First Posted: 2021-08-16
• Last Update Submitted: 2021-11-15
• Last Update Posted: 2021-11-23
• Primary Completion: 2022-02-28
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
10 to below 14 kg weight band	DTG DT 20 mg	Children with perinatal HIV infection whose weight from 10 kg to below 14 kg
6 to below 10 kg weight band	DTG DT 20 mg	Children with perinatal HIV infection whose weight from 6 kg to below 10 kg
14 to below 20 kg weight band	DTG DT 25 mg	Children with perinatal HIV infection whose weight from 14 kg to below 20 kg

Primary Outcome Measures

Name	Time	Method
Steady-state pharmacokinetics of DTG dispersible tablets in children with HIV infection	At 7-14 day after started on DTG	Trough plasma DTG concentration and DTG exposure (AUC24h)

Secondary Outcome Measures

Name	Time	Method
Serious adverse event incidence	24 week after medication switched	Incidence of grade 3 and 4 adverse events in use of DTG for HIV treatment in
Antiretroviral activity of dolutegravir dispersible tablets combined with two standard background therapies	24 week after medication switched	HIV VL \<40 copies/mL

Trial Locations

Locations (1)

Division of Infectious disease, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University; 🇹🇭 Bangkok, Thailand