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)
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Give 2 tabs of MYLTEGA DT (10mg) PO once daily
Give 2.5 tabs of MYLTEGA DT (10mg) PO once daily
Division of Infectious disease, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University
Bangkok, Thailand
RECRUITINGSteady-state pharmacokinetics of DTG dispersible tablets in children with HIV infection
Trough plasma DTG concentration and DTG exposure (AUC24h)
Time frame: At 7-14 day after started on DTG
Serious adverse event incidence
Incidence of grade 3 and 4 adverse events in use of DTG for HIV treatment in
Time frame: 24 week after medication switched
Antiretroviral activity of dolutegravir dispersible tablets combined with two standard background therapies
HIV VL \<40 copies/mL
Time frame: 24 week after medication switched
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