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

Chulalongkorn University

Status and phase: Unknown; Phase 2

Conditions: Pediatric HIV Infection

Treatments: Drug: DTG DT 20 mg; Drug: DTG DT 25 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05006170

DTGkids

Details and patient eligibility

About

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)

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 3 months to 7 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

6 to below 10 kg weight band

Experimental group

Description:

Children with perinatal HIV infection whose weight from 6 kg to below 10 kg

Treatment:

Drug: DTG DT 20 mg

10 to below 14 kg weight band

Experimental group

Description:

Children with perinatal HIV infection whose weight from 10 kg to below 14 kg

Treatment:

Drug: DTG DT 20 mg

14 to below 20 kg weight band

Experimental group

Description:

Children with perinatal HIV infection whose weight from 14 kg to below 20 kg

Treatment:

Drug: DTG DT 25 mg