Pediatric HIV Infection
Conditions
Keywords
dolutegravir dispersible tablet, pharmacokinetics, weight below 20 kg
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.
Interventions
DRUGDTG DT 20 mg
Give 2 tabs of MYLTEGA DT (10mg) PO once daily
DRUGDTG DT 25 mg
Give 2.5 tabs of MYLTEGA DT (10mg) PO once daily
Sponsors
Chulalongkorn University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Each participants will undergo ARTs medication switch to DTG dispersible tablet, and ABC/3TC dispersible tablet
Eligibility
Sex/Gender
ALL
Age
3 Months to 7 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Steady-state pharmacokinetics of DTG dispersible tablets in children with HIV infection | At 7-14 day after started on DTG | Trough plasma DTG concentration and DTG exposure (AUC24h) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serious adverse event incidence | 24 week after medication switched | 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 | 24 week after medication switched | HIV VL \<40 copies/mL |
Countries
Thailand
Contacts
Primary ContactAthiporn Premgamone, MD
Backup ContactThanyawee Puthanakit, MD
Outcome results
None listed