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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 6 to below 10 kg weight band | Experimental | Children with perinatal HIV infection whose weight from 6 kg to below 10 kg |
|
| 10 to below 14 kg weight band | Experimental | Children with perinatal HIV infection whose weight from 10 kg to below 14 kg |
|
| 14 to below 20 kg weight band | Experimental | Children with perinatal HIV infection whose weight from 14 kg to below 20 kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DTG DT 20 mg | Drug | Give 2 tabs of MYLTEGA DT (10mg) PO once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Antiretroviral activity of dolutegravir dispersible tablets combined with two standard background therapies |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Athiporn Premgamone, MD | Contact | +6622564000 | 4930 | athiporn.p@chula.ac.th |
| Thanyawee Puthanakit, MD | Contact | +6622564000 | 4930 | thanyawee.p@chula.ac.th |
| Name | Affiliation | Role |
|---|---|---|
| Athiporn Premgamone, MD | Chulalongkorn University | Principal Investigator |
| Thanyawee Puthanakit, MD | Chulalongkorn University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Infectious disease, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University | Recruiting | Bangkok | 10330 | Thailand |
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| ID | Term |
|---|---|
| C562325 | dolutegravir |
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Each participants will undergo ARTs medication switch to DTG dispersible tablet, and ABC/3TC dispersible tablet
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| DTG DT 25 mg | Drug | Give 2.5 tabs of MYLTEGA DT (10mg) PO once daily |
|
|
HIV VL <40 copies/mL |
| 24 week after medication switched |