New HIV pill dose for kids shows promise in african study
NCT ID NCT05993767
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a new combination of three HIV drugs (dolutegravir, emtricitabine, and tenofovir alafenamide) in 53 children aged 28 days to 10 years in Africa. The goal was to find a dose that gives enough medicine in the blood and is safe. If it works, this could lead to a single, easy-to-take pill for children living with HIV.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dolutegravir, emtricitabine, and tenofovir alafenamide (three anti-HIV drugs combined)
- What this could lead to
- If successful, this could lead to a simpler, child-friendly pill that helps control HIV in children across Africa.
- What could go wrong
- This is a small, early-phase study (53 children) focused on drug levels and safety, not on long-term cure. The new dose may not work for all children or could have side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
53 people
The number who actually took part.
- Started
-
Dec 2024
- Finished
-
Jan 2026
- Lead sponsor
-
A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
28 days to 10 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Baylor College of Medicine Children's Foundation
Kampala, Uganda
-
Joint Research Centre
Kampala, Uganda
-
University of Zimbabwe Clinical Research Centre
Harare, Zimbabwe
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