Status:
ACTIVE_NOT_RECRUITING
UNIVERSAL 1: Pharmacokinetic Study of a Novel DTG/FTC/TAF Dose Ratio for Children
Lead Sponsor:
PENTA Foundation
Collaborating Sponsors:
Radboud University Medical Center
Baylor College of Medicine
Conditions:
HIV Infection
Eligibility:
All Genders
28-10 years
Phase:
PHASE2
Brief 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 wi...
Detailed Description
Dolutegravir (DTG), Emtricitabine (FTC) and Tenofovir alafenamide (TAF) are anti-HIV medicines. DTG works very well, can be taken once-daily and has few side effects. In international treatment guidel...
Eligibility Criteria
Inclusion
- Age between 28 days and 10 years old
- Weighing 3 to \<25 kg
- Confirmed HIV-1 infection (local, molecular methods)
- A parent or legal guardian is willing and able to give informed consent on behalf of the child as per national legislation and willing to adhere to the protocol
- Participant is willing to give informed assent if the trial site clinician deems them old enough and able to understand the age-appropriate information about participation in the study
- Girls who have reached menarche must have a negative pregnancy test at screening
- Subject is willing to start DTG/FTC/TAF regimen in the novel dose ratio for HIV treatment
- Subjects already on a DTG-based ART regimen should be virologically suppressed at screening
Exclusion
- Age between 28 days and 10 years old
- Weighing 3 to \<25 kg
- Confirmed HIV-1 infection (local, molecular methods)
- A parent or legal guardian is willing and able to give informed consent on behalf of the child as per national legislation and willing to adhere to the protocol
- Participant is willing to give informed assent if the trial site clinician deems them old enough and able to understand the age-appropriate information about participation in the study
- Girls who have reached menarche must have a negative pregnancy test at screening
- Subject is willing to start DTG/FTC/TAF regimen in the novel dose ratio for HIV treatment
- Subjects already on a DTG-based ART regimen should be virologically suppressed at screening
- History or presence of known allergy to DTG, FTC or TAF
- Alanine aminotransferase (ALT) ≥5 times the upper limit of normal (ULN), OR ALT ≥3xULN AND bilirubin ≥2xULN
- Patients with severe hepatic impairment or unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
- Current or anticipated need for TB therapy during the study
- Use of rifampicin-based therapy within 4 weeks before start trial
- Presence of comedication known to interact with trial medications
- Known resistance to INSTI or NRTI
Key Trial Info
Start Date :
December 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05993767
Start Date
December 11 2024
End Date
December 30 2025
Last Update
September 2 2025
Active Locations (3)
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1
Baylor College of Medicine Children's Foundation
Kampala, Uganda
2
Joint Research Centre
Kampala, Uganda
3
University of Zimbabwe Clinical Research Centre
Harare, Zimbabwe