Can new HIV drug mixes keep more children Virus-Free?

NCT ID NCT07792096

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This trial compares different HIV drug combinations in children and teens aged 4 weeks to under 15 years, including those starting treatment for the first time and those whose current drugs are failing. Researchers want to see which combinations best keep the virus at very low levels after 48 weeks, while being safe and easy to take. Participants take their assigned daily medication and attend clinic visits over 1 to 2 years for blood tests, health checks, and simple questionnaires about wellbeing and quality of life. The goal is to find the most effective and tolerable HIV treatments for young people in Africa.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Combinations of HIV medicines including dolutegravir, abacavir, and lamivudine
What this could lead to
If successful, this could identify safer and more effective HIV treatment combinations for children, improving long-term health and quality of life.
What could go wrong
The trial is large but results depend on real-world adherence and may not apply to all settings. Some drug combinations may cause side effects or fail to control the virus in some children.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 800 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

4 weeks to 14 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: 1. Aged ≥ 4 weeks to \<15 years\* with confirmed HIV infection 2. Weight ≥3kg and \<30kg\* 3. Written informed consent obtained (and assent if applicable) 4. Willing to adhere to a minimum of 48 weeks' follow-up * Upper limits of 15 years and 30kg are for initial treatment options and may be amended when further treatment options are introduced (through a protocol amendment) ART-NAÏVE 1. Planning to start first-line ART 2. Virologically unsuppressed with VL ≥400 c/mL at screening ART-EXPERIENCED 1. ART-experienced, and on DTG-based ART, and have been on DTG-based ART for at least 6-months prior to screening 2. Virologically unsuppressed for at least 3 months, demonstrated by two consecutive VLs ≥400 c/mL in the last year; the second VL must be at screening 3. Received adherence counselling as per standard practice prior to screening EXCLUSION CRITERIA 1. Alanine aminotransferase (ALT) ≥5 times the upper limit of normal (ULN), OR both ALT ≥3xULN and bilirubin ≥2xULN at screening\*\* 2. 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) 3. Severe renal impairment, defined as creatinine clearance \<30 mL/min/1.73m2, at screening\*\* 4. Severe life-threatening illness (not expected to survive beyond two weeks) as determined by the investigator's clinical judgment. 5. Eligible for less than two permitted treatment options based on tables 3 (ART-naive participants) and 4 (ART-experienced participants) 6. Concurrent participation in another clinical trial of an investigational medicinal product (IMP), medical device or other intervention. * If ALT, bilirubin or creatinine results are available before randomisation and meet exclusion criteria, the child should not be randomised. However, randomisation may proceed while awaiting these results. If results become available after randomisation and meet exclusion criteria, the participant must be recalled and withdrawn from the trial and the InCTU trial physician contacted to discuss clinical management.

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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