Rifapentine and Isoniazid TB Preventive Therapy (3HP) for Children Taking Dolutegravir-based Antiretroviral Treatment (DOLPHIN KIDS)

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

92

Participants

Timeline

Start Date

May 24, 2023

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2025

Conditions
TuberculosisHIV
Interventions
DRUG

Dolutegravir

"Groups 1a/1b: Participants will take the FDA-approved weight-based DTG once daily + either TDF/FTC, TDF/3TC, ABC/3TC or AZT/3TC x 4 weeks. During HP treatment and for two weeks afterward, DTG dose will be increased to twice daily.~Participants will continue with the NRTI regimen they have previously tolerated, except where their age and weight allow them to transition from either AZT or ABC to TDF, as per South African National ART Guidelines. HLA-B\*5701 screening will therefore not be performed, as children will be currently taking and tolerating an ABC-containing regimen at enrolment. If any clinically suspected hypersensitivity reaction to ABC is suspected by history, ABC will not be continued.~Groups 2a/2b: Participants will take weight-based DTG dosing twice or once daily, depending on the results of the modelled data for the Group 1a (for Group 2a) and/or Group 1b (for Group 2b) participants in the interim analysis."

DRUG

3HP

3HP Dosing is by Age and Weight Children 2-15 years of age: 10-15kg (P 300mg, H 300mg); 16-23kg (P 450mg, H 500mg); 24-30kg (P 600mg, H 600mg); 31-34kg (P 750mg, H 700mg). Children 15-17 years, \>=30kg (P 900mg, H 900mg)

Trial Locations (2)

2571

RECRUITING

Peri Natal HIV Research Unit - Klerksdorp Tshepong Hospital, Klerksdorp

0087

RECRUITING

The Aurum Institute: Pretoria Clinical Research Centre, Pretoria

All Listed Sponsors
collaborator

Johns Hopkins University

OTHER

lead

The Aurum Institute NPC

OTHER