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New HIV pill dose for kids shows promise in african study

NCT ID NCT05993767

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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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