A Phase 2 interventional study of DTG DT 20 mg and DTG DT 25 mg in Pediatric HIV Infection, sponsored by Chulalongkorn University. Status unknown at 1 site in Thailand. Open to participants aged 3 Months to 7 Years. Per ClinicalTrials.gov, last updated 2021-11-23.
Sponsored by Chulalongkorn University · Phase 2, Interventional, and Treatment
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.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's planned enrollment of 30 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Chulalongkorn University is the lead sponsor of 312 studies on the registry; 59 are open to participants now.
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Exclusion criteria:
Children with perinatal HIV infection whose weight from 6 kg to below 10 kg
Drug: DTG DT 20 mg
Children with perinatal HIV infection whose weight from 10 kg to below 14 kg
Drug: DTG DT 20 mg
Children with perinatal HIV infection whose weight from 14 kg to below 20 kg
Drug: DTG DT 25 mg
Give 2 tabs of MYLTEGA DT (10mg) PO once daily
Also known as: MYLTEGA Dispersible Tablet
Give 2.5 tabs of MYLTEGA DT (10mg) PO once daily
Also known as: MYLTEGA DT Dispersible Tablet
Steady-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
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Chulalongkorn University