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

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)

Study Overview

• Status: Recruiting
• Conditions: Pediatric HIV Infection
• Intervention / Treatment: Drug: DTG DT 20 mg; Drug: DTG DT 25 mg

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Athiporn Premgamone, MD; Phone Number: 4930 +6622564000; Email: athiporn.p@chula.ac.th
• Study Contact Backup: Name: Thanyawee Puthanakit, MD; Phone Number: 4930 +6622564000; Email: thanyawee.p@chula.ac.th

Study Locations

• Thailand
  • Bangkok, Thailand, 10330
    • Recruiting
    • Division of Infectious disease, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University
    • Contact: Athiporn Premgamone, MD; Phone Number: 4930 +6622564000; Email: athiporn.p@chula.ac.th
    • Contact: Thanyawee Puthanakit, MD; Phone Number: 4930 +6622564000; Email: thanyawee.p@chula.ac.th

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 7 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 6 to below 10 kg weight band; Children with perinatal HIV infection whose weight from 6 kg to below 10 kg	Drug: DTG DT 20 mg; Give 2 tabs of MYLTEGA DT (10mg) PO once daily; Other Names: MYLTEGA Dispersible Tablet
EXPERIMENTAL: 10 to below 14 kg weight band; Children with perinatal HIV infection whose weight from 10 kg to below 14 kg	Drug: DTG DT 20 mg; Give 2 tabs of MYLTEGA DT (10mg) PO once daily; Other Names: MYLTEGA Dispersible Tablet
EXPERIMENTAL: 14 to below 20 kg weight band; Children with perinatal HIV infection whose weight from 14 kg to below 20 kg	Drug: DTG DT 25 mg; Give 2.5 tabs of MYLTEGA DT (10mg) PO once daily; Other Names: MYLTEGA DT Dispersible Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chulalongkorn University
• Investigators: Principal Investigator: Athiporn Premgamone, MD, Chulalongkorn University; Principal Investigator: Thanyawee Puthanakit, MD, Chulalongkorn University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 3, 2021
• Primary Completion (ANTICIPATED): February 28, 2022
• Study Completion (ANTICIPATED): June 30, 2022

Study Registration Dates

• First Submitted: August 4, 2021
• First Submitted That Met QC Criteria: August 7, 2021
• First Posted (ACTUAL): August 16, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 23, 2021
• Last Update Submitted That Met QC Criteria: November 15, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: pharmacokinetics; dolutegravir dispersible tablet; weight below 20 kg
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: DTGkids

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No