UNIVERSAL 1: Pharmacokinetic Study of a Novel DTG/FTC/TAF Dose Ratio for Children
Status:
ACTIVE_NOT_RECRUITING
Trial end date:
2025-12-30
Target enrollment:
Participant gender:
Summary
This study aims to find out whether treating children living with HIV with three anti-HIV medicines, dolutegravir (DTG), emtricitabine (FTC) and tenofovir alafenamide (TAF), with a novel dose ratio will achieve adequate drug concentrations and is safe. The optimal DTG/FTC/TAF dose ratio will be used for the development of a fixed-dose combination dispersible tablet.
Phase:
PHASE2
Details
Lead Sponsor:
PENTA Foundation
Collaborators:
Baylor College of Medicine Chiang Mai University Clinton Health Access Initiative Inc. Joint Clinical Research Center Radboud University Medical Center University of Zimbabwe