UNIVERSAL 1: Pharmacokinetic Study of a Novel DTG/FTC/TAF Dose Ratio for Children - Trial NCT05993767
Access comprehensive clinical trial information for NCT05993767 through Pure Global AI's free database. This Phase 2 trial is sponsored by PENTA Foundation and is currently Not yet recruiting. The study focuses on HIV Infection. Target enrollment is 50 participants.
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Study Focus
dolutegravir (DTG)/emtricitabine (FTC)/tenofovir alafenamide (TAF) regimen
Interventional
drug
Sponsor & Location
PENTA Foundation
Timeline & Enrollment
Phase 2
Jan 31, 2024
Dec 31, 2025
Primary Outcome
Primary endpoints for DTG:,Primary endpoints for DTG:,Primary endpoints for DTG:,Primary safety endpoints,Primary safety endpoints,Primary safety endpoints,Primary endpoints for FTC/TAF:,Primary endpoints for FTC/TAF:
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05993767
Non-Device Trial