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NCT05993767

UNIVERSAL 1: Pharmacokinetic Study of a Novel DTG/FTC/TAF Dose Ratio for Children

Pharmacokinetic Study of an Optimized Dose Ratio of Dolutegravir/Emtricitabine/Tenofovir Alafenamide Fumarate: Expediting a UNIVERSAL First Line Regimen for All Children Living With HIV in Africa
PENTA Foundation·Phase 2·ClinicalTrials.gov·drugNot yet recruiting
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Study focus
Disease/Condition
HIV Infection
Drug/Device/Intervention
dolutegravir (DTG)/emtricitabine (FTC)/tenofovir alafenamide (TAF) regimen
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
PENTA Foundation
Timeline & enrollment
Phase
Phase 2
Start date
Jan 31, 2024
End date
Dec 31, 2025
Enrollment
50 participants
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
HIV disease resulting in other viral infectionsHuman immunodeficiency virus [HIV] diseaseHIV disease resulting in other bacterial infectionsAcute HIV infection syndromeUnspecified human immunodeficiency virus [HIV] disease
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05993767
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.