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

Primary Purpose

Pediatric HIV Infection

Status

Unknown status

Phase

Phase 2

Locations

Thailand

Study Type

Interventional

Intervention

DTG DT 20 mg

DTG DT 25 mg

About this trial

This is an interventional treatment trial for Pediatric HIV Infection focused on measuring dolutegravir dispersible tablet, pharmacokinetics, weight below 20 kg

Eligibility Criteria

3 Months - 7 Years (Child)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

6 to below 10 kg weight band

10 to below 14 kg weight band

14 to below 20 kg weight band

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Trough plasma DTG concentration and DTG exposure (AUC24h)

Secondary Outcome Measures

Serious adverse event incidence

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

HIV VL <40 copies/mL

Full Information

NCT ID

NCT05006170

First Posted

August 4, 2021

Last Updated

November 15, 2021

Sponsor

Chulalongkorn University

1. Study Identification

Unique Protocol Identification Number

NCT05006170

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Unknown status

Study Start Date

August 3, 2021 (Actual)

Primary Completion Date

February 28, 2022 (Anticipated)

Study Completion Date

June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chulalongkorn University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pediatric HIV Infection

Keywords

dolutegravir dispersible tablet, pharmacokinetics, weight below 20 kg

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

6 to below 10 kg weight band

Arm Type

Experimental

Arm Description

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

Arm Title

10 to below 14 kg weight band

Arm Type

Experimental

Arm Description

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

Arm Title

14 to below 20 kg weight band

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

DTG DT 20 mg

Other Intervention Name(s)

MYLTEGA Dispersible Tablet

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

DTG DT 25 mg

Other Intervention Name(s)

MYLTEGA DT Dispersible Tablet

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Trough plasma DTG concentration and DTG exposure (AUC24h)

Time Frame

At 7-14 day after started on DTG

Secondary Outcome Measure Information:

Title

Serious adverse event incidence

Description

Incidence of grade 3 and 4 adverse events in use of DTG for HIV treatment in

Time Frame

24 week after medication switched

Title

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

Description

HIV VL <40 copies/mL

Time Frame

24 week after medication switched

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Months

Maximum Age & Unit of Time

7 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Athiporn Premgamone, MD

Phone

+6622564000

Ext

4930

athiporn.p@chula.ac.th

First Name & Middle Initial & Last Name or Official Title & Degree

Thanyawee Puthanakit, MD

Phone

+6622564000

Ext

4930

thanyawee.p@chula.ac.th

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Athiporn Premgamone, MD

Organizational Affiliation

Chulalongkorn University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Thanyawee Puthanakit, MD

Organizational Affiliation

Chulalongkorn University

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Athiporn Premgamone, MD

Phone

+6622564000

Ext

4930

athiporn.p@chula.ac.th

First Name & Middle Initial & Last Name & Degree

Thanyawee Puthanakit, MD

Phone

+6622564000

Ext

4930

thanyawee.p@chula.ac.th

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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