Pharmacokinetic, safety, and efficacy of dolutegravir dispersible tablet in young children living with HIV.

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20201025001

Enrollment

Registered

2020-10-25

Start date

2021-01-01

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

children with HIV infection BW 6&#45

Interventions

Participant will receive DTG dispersible tablet as their weight band dosing 20 mg for weight 6&#45

<10&#44

10&#45

<14 kg&#44

and 25 mg for weight 14&#45

<20kg

Experimental Drug

DTG dispersible tablet

Eligibility

Sex/Gender

All

Age

3 Months to 6 Years

Inclusion criteria

Inclusion criteria: 1. children with HIV infection weight 6-<20 kg 2. never receiving integrase inhibitor for treat their HIV

Exclusion criteria

Exclusion criteria: 1. active HIV disease or active opportunistic infection 2. liver impairment (ALT >100 IU/mL) 3. Renal impairment (GFR <60 mL/min) 4. concurrently treat with drug which have drug interaction to DTG

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics of dolutegravir dispersible tablet in children living with HIV weighting 6-20 kg 24 hrs plasma dolutegravir level	—

Secondary

Measure	Time frame
Antiviral activity of dolutegravir combine with 2 background ARVs 24 weeks percentage of virologically suppressed,safety of dolutegravir combine with 2 backgroud ARV 24 weeks percentage of incidence of grade 3,4 adverse event	—

Countries

Thailand

Contacts

Public ContactAthiporn Premgamone

Faculty of Medicine, Chulalongkorn University

p.athiporn@gmail.com66868560874

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026

Pharmacokinetic&#44; safety&#44; and efficacy of dolutegravir dispersible tablet in young children living with HIV.