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

NCT05006170 | Unknown Phase 2 DMC

• 1 other identifier: DTGkids
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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)

Conditions

Pediatric HIV Infection

Keywords

dolutegravir dispersible tablet; pharmacokinetics; weight below 20 kg

Outcome Measures

Primary Outcomes (1)

• Steady-state pharmacokinetics of DTG dispersible tablets in children with HIV infection

  Trough plasma DTG concentration and DTG exposure (AUC24h)

  At 7-14 day after started on DTG

Secondary Outcomes (2)

• Serious adverse event incidence

  24 week after medication switched

• Antiretroviral activity of dolutegravir dispersible tablets combined with two standard background therapies

  24 week after medication switched

Study Arms (3)

6 to below 10 kg weight band

EXPERIMENTAL

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

Drug: DTG DT 20 mg

10 to below 14 kg weight band

EXPERIMENTAL

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

Drug: DTG DT 20 mg

14 to below 20 kg weight band

EXPERIMENTAL

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

Drug: DTG DT 25 mg

Interventions

DTG DT 20 mg DRUG

Give 2 tabs of MYLTEGA DT (10mg) PO once daily

Also known as: MYLTEGA Dispersible Tablet

10 to below 14 kg weight band; 6 to below 10 kg weight band

DTG DT 25 mg DRUG

Give 2.5 tabs of MYLTEGA DT (10mg) PO once daily

Also known as: MYLTEGA DT Dispersible Tablet

14 to below 20 kg weight band

Eligibility Criteria

• Age: 3 Months - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children living with HIV weighing 6 to below 20 kg
• Naïve to integrase inhibitors

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Division of Infectious disease, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University

Bangkok, 10330, Thailand

RECRUITING

MeSH Terms

Interventions

dolutegravir

Study Officials

• Athiporn Premgamone, MD

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

• Thanyawee Puthanakit, MD

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Athiporn Premgamone, MD

CONTACT

+6622564000; athiporn.p@chula.ac.th

Thanyawee Puthanakit, MD

CONTACT

+6622564000; thanyawee.p@chula.ac.th

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participants will undergo ARTs medication switch to DTG dispersible tablet, and ABC/3TC dispersible tablet

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 16, 2021
• Study Start: August 3, 2021
• Primary Completion: February 28, 2022
• Study Completion: June 30, 2022
• Last Updated: November 23, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)