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

Phase 1

• Conditions: children with HIV infection BW 6&#45; <20 kg; DTG dispersible tablet; HIV; dolutegravir; pharmacokinetics

• Registration Number: TCTR20201025001
• Lead Sponsor: Faculty of Medicine&#44; Chulalongkorn University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-25
• Study Completion: 2021-07-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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