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

Pediatric HIV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05006170
• Other study ID #: DTGkids
• Status: Recruiting
• Phase: Phase 2
• Start date: August 3, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2021
• Source: Chulalongkorn University
• Contact: Athiporn Premgamone, MD
• Phone: +6622564000
• Email: athiporn.p[@]chula.ac.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 30, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections
• Pediatric HIV Infection

Intervention

Drug:
• DTG DT 20 mg
Give 2 tabs of MYLTEGA DT (10mg) PO once daily
• DTG DT 25 mg
Give 2.5 tabs of MYLTEGA DT (10mg) PO once daily

Locations

Country	Name	City	State
Thailand	Division of Infectious disease, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Antiretroviral activity of dolutegravir dispersible tablets combined with two standard background therapies	HIV VL <40 copies/mL	24 week after medication switched