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

NCT05006170 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-11-23

No results posted yet for this study

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

Interventions

DRUG

DTG DT 20 mg

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

DRUG

DTG DT 25 mg

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

Sponsors & Collaborators

  • Chulalongkorn University

    lead OTHER

Principal Investigators

  • Athiporn Premgamone, MD · Chulalongkorn University

  • Thanyawee Puthanakit, MD · Chulalongkorn University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Months
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-03
Primary Completion
2022-02-28
Completion
2022-06-30

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05006170 on ClinicalTrials.gov