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

NCT05993767 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2026-03-04

No results posted yet for this study

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.

Conditions

  • HIV Infection

Interventions

DRUG

dolutegravir (DTG)/emtricitabine (FTC)/tenofovir alafenamide (TAF) regimen

Switch or start dolutegravir (DTG)/emtricitabine (FTC)/tenofovir alafenamide (TAF) regimen with a novel dose ratio for HIV treatment

DRUG

Dolutegravir (DTG)/ Emtricitabine (FTC)/tenofovir alafenamide (TAF)

Single arm

Sponsors & Collaborators

  • Radboud University Medical Center

    collaborator OTHER

  • Baylor College of Medicine

    collaborator OTHER

  • Clinton Health Access Initiative Inc.

    collaborator OTHER

  • University of Zimbabwe

    collaborator OTHER

  • Chiang Mai University

    collaborator OTHER

  • Joint Clinical Research Center

    collaborator OTHER

  • PENTA Foundation

    lead NETWORK

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
28 Days
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-11
Primary Completion
2025-06-30
Completion
2026-01-20

Countries

  • Uganda
  • Zimbabwe

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05993767 on ClinicalTrials.gov