NCT05993767CompletedPhase 2
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
Source: ClinicalTrials.gov · Last updated 4 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 53 (actual)
- First submitted
- 1 Aug 2023
- Start date
- 11 Dec 2024
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- PENTA Foundation
- Diseases
- HIV
- NCT number
- NCT05993767
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 53
- From 11 Dec 2024 to the primary completion date, 30 Jun 2025
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Confirmed HIV-1 infection (local, molecular methods)
- Subject is willing to start DTG/FTC/TAF regimen in the novel dose ratio for HIV treatment
- History or presence of known allergy to DTG, FTC or TAF
- 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)
Lab values
- Alanine aminotransferase (ALT) ≥5 times the upper limit of normal (ULN), OR ALT ≥3xULN AND bilirubin ≥2xULN
Age
- Age between 28 days and 10 years old
- 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
Other
- Weighing 3 to \<25 kg
- 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
- Girls who have reached menarche must have a negative pregnancy test at screening
- Subjects already on a DTG-based ART regimen should be virologically suppressed at screening
- Known resistance to INSTI or NRTI
Who the study is looking for
- 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
Age in the registry: 28 days to 10 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Joint Research Centre Coordinator of this site? Confirm its status | Kampala | Uganda | Unknown status |
| Baylor College of Medicine Children's Foundation Coordinator of this site? Confirm its status | Kampala | Uganda | Unknown status |
| University of Zimbabwe Clinical Research Centre Coordinator of this site? Confirm its status | Harare | Zimbabwe | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.