92
Participants
Start Date
May 24, 2023
Primary Completion Date
December 31, 2024
Study Completion Date
December 31, 2025
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."
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)
RECRUITING
Peri Natal HIV Research Unit - Klerksdorp Tshepong Hospital, Klerksdorp
RECRUITING
The Aurum Institute: Pretoria Clinical Research Centre, Pretoria
Johns Hopkins University
OTHER
The Aurum Institute NPC
OTHER