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

NCT ID: NCT05006170

Last Updated: 2021-11-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-03
• Study Completion Date: 2022-06-30

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.

Conditions

Pediatric HIV Infection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

6 to below 10 kg weight band

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

Group Type: EXPERIMENTAL

DTG DT 20 mg

Intervention Type: DRUG

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

10 to below 14 kg weight band

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

Group Type: EXPERIMENTAL

DTG DT 20 mg

Intervention Type: DRUG

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

14 to below 20 kg weight band

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

Group Type: EXPERIMENTAL

DTG DT 25 mg

Intervention Type: DRUG

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

Interventions

DTG DT 20 mg

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

Intervention Type: DRUG

DTG DT 25 mg

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

Intervention Type: DRUG

Other Intervention Names

MYLTEGA Dispersible Tablet; MYLTEGA DT Dispersible Tablet

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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chulalongkorn University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Athiporn Premgamone, MD

Role: PRINCIPAL_INVESTIGATOR

Chulalongkorn University

Thanyawee Puthanakit, MD

Role: PRINCIPAL_INVESTIGATOR

Chulalongkorn University

Locations

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

Bangkok, , Thailand

Site Status: RECRUITING

Countries

Thailand

Central Contacts

Athiporn Premgamone, MD

Role: CONTACT

athiporn.p@chula.ac.th

+6622564000 ext. 4930

Thanyawee Puthanakit, MD

Role: CONTACT

thanyawee.p@chula.ac.th

+6622564000 ext. 4930

Facility Contacts

Athiporn Premgamone, MD

Role: primary

athiporn.p@chula.ac.th

+6622564000 ext. 4930

Thanyawee Puthanakit, MD

Role: backup

thanyawee.p@chula.ac.th

+6622564000 ext. 4930

Other Identifiers

DTGkids

Identifier Type: -

Identifier Source: org_study_id