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

Study Overview
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Brief Summary
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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)

Detailed Description
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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.

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

Conditions
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Pediatric HIV Infection

Intervention / Treatment
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* Drug: DTG DT 20 mg
* Drug: DTG DT 25 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Each participants will undergo ARTs medication switch to DTG dispersible tablet, and ABC/3TC dispersible tablet
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 6 to below 10 kg weight band<br>Children with perinatal HIV infection whose weight from 6 kg to below 10 kg | Drug: DTG DT 20 mg<br>* Give 2 tabs of MYLTEGA DT (10mg) PO once daily<br>* Other names: MYLTEGA Dispersible Tablet;|
| Experimental: 10 to below 14 kg weight band<br>Children with perinatal HIV infection whose weight from 10 kg to below 14 kg | Drug: DTG DT 20 mg<br>* Give 2 tabs of MYLTEGA DT (10mg) PO once daily<br>* Other names: MYLTEGA Dispersible Tablet;|
| Experimental: 14 to below 20 kg weight band<br>Children with perinatal HIV infection whose weight from 14 kg to below 20 kg | Drug: DTG DT 25 mg<br>* Give 2.5 tabs of MYLTEGA DT (10mg) PO once daily<br>* Other names: MYLTEGA DT Dispersible Tablet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | HIV VL <40 copies/mL | 24 week after medication switched | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dolutegravir dispersible tablet, pharmacokinetics, weight below 20 kg