CompletedPhase II/IIIInterventional

Comparing a two-drug fixed dose combination containing dolutegravir and lamivudine to the usual three-drug combination for maintenance treatment in children aged 2-14 years with HIV infection living in Europe, Thailand and Africa

Most children living with HIV take a combination of three or four medicines every day to keep the virus under control. While these treatments work very well, taking several medicines for life can cause unwanted side effects and be hard to keep up with. This study is testing whether a simpler treatment combining just two medicines—dolutegravir and lamivudine—is just as safe and effective as the usual three-drug combinations. The study involves children and young people aged 2 to 14 whose HIV is already well controlled. Half will switch to the new two-drug tablet (either swallowed whole or dissolved in water), while the other half will stay on their current medication. Researchers will monitor their health and blood tests over roughly two years to see if this simpler approach makes daily treatment easier without losing viral control.

At a glance

Status

Completed

Phase

Phase II/III

Sponsor

PENTA Foundation

Enrolment target

370

Start

30 Apr 2021

Estimated completion

28 Sep 2023

HIV infection in children

What is this study about?

Human immunodeficiency virus (HIV) weakens the immune system, making it harder for the body to fight off everyday infections. Thanks to modern treatments known as antiretroviral therapy, people living with HIV can lead long, healthy, and active lives. However, standard care usually requires taking a mix of three or four medicines every single day to stop the virus from multiplying.

Because children must stay on treatment throughout their lives, doctors are searching for options that are gentler on the body and easier to stick to. Taking fewer medicines may lower the risk of long-term side effects and make taking daily tablets less of a burden for children and their families. Dolutegravir and lamivudine are two well-established medicines that are already proven to work well together in adults.

This international study aims to find out if this two-drug combination is just as safe and effective for children and teenagers. By comparing the two-drug option with standard three-drug treatments, researchers hope to give young people around the world access to simpler, lighter daily routines.

Key takeaways

Tests whether a two-drug treatment works as well as the standard three-drug therapy for children with HIV.
Aimed at children aged 2 to 14 whose virus is already well controlled.
Medicines are taken once daily as a swallowable tablet or dissolved in water.
Participants are followed for around two years with regular routine-style check-ups and blood tests.
Taking fewer medicines may mean fewer long-term side effects and a simpler daily routine.

Who may be eligible?

Children and young people aged between 2 and 14 years old who are living with HIV-1 may be able to join this study. To take part, their virus must already be well controlled (undetectable or virologically suppressed) for at least the last six months on their current medication. They must also have been taking the same three-drug combination for at least three months.

Participants must weigh at least 6 kilograms (around 13 pounds). Because the safety of these medicines during early pregnancy is still being carefully checked, girls who have started their periods will need a negative pregnancy test before joining, and anyone who is sexually active must agree to use reliable contraception.

A parent or legal guardian must give full written permission (consent) for their child to take part. If the child is old enough to understand what the study involves, they will also have the study explained to them and be asked if they are happy to agree (assent).

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

The child is aged between 2 and 14 years old.
The child weighs at least 6 kilograms (13 pounds).
The child has had well-controlled HIV levels for at least the past 6 months.
The child has been taking the same three-drug HIV treatment for at least 3 months.
A parent or legal guardian is willing to give consent for the study.

Answer every question to see your result.

What does participation involve?

Taking part in this study lasts for up to 96 weeks (about two years). Children are put into one of two groups by chance (randomly). One group will continue taking their usual three-drug medicine, while the other group will switch to the new two-drug combination. Depending on their weight, children taking the new combination will either take one small tablet once a day, or dissolve a few small dispersible tablets in a little water once a day.

Clinic visits will happen regularly and are planned to fit closely with normal routine HIV check-ups. At these visits, the medical team will check the child's overall health and growth, and take blood tests to check viral levels and ensure the medication remains safe. Parents and children will also answer short questionnaires about what it feels like to take the medication.

Potential risks and benefits

Children taking the new combination might benefit from having to take fewer tablets each day, which could lead to fewer long-term side effects. However, there is no guarantee of direct personal benefit, though the results will help improve HIV care for other children globally. Like all medicines, dolutegravir and lamivudine can cause mild side effects such as headaches, tummy aches, feeling sick, diarrhoea, tiredness, or mild skin rashes. Doctors will watch every child very closely throughout the trial. Joining is completely voluntary, and parents or young people can choose to stop participating at any time without it affecting the child's standard NHS or routine care.

Locations (16)

Great Ormond Street Hospital for Children
Approximate
London, England
Birmingham Heartlands Hospital
Approximate
Birmingham, England
St Mary’s Hospital
Approximate
London, England
Chris Hani Baragwanath Hospital
City only
Soweto, South Africa
Klerksdorp/Tsepong Hospital Complex
City only
Matlosana, South Africa
King Edward VIII Hospital
Unverified
Durban, South Africa
Hospital Universitario 12 de Octubre
Unverified
Madrid, Spain
Hospital Sant Joan de Déu
Unverified
Espluges, Spain
Prapokklao Hospital
Unverified
Chantaburi, Thailand
Chiangrai Prachanukroh Hospital
Unverified
Chiang Rai, Thailand
Nakornping Hospital
Unverified
Chiang Mai, Thailand
Khon Kaen Hospital
Unverified
Khon Kaen, Thailand

Common questions

Will my child definitely get the new two-drug medicine?

Not necessarily. A computer places children into one of two groups by chance. Half will switch to the new combination, and half will stay on their usual treatment.

How does the child take the new medicine?

Depending on their weight, children either swallow one small tablet once daily, or take dispersible tablets that dissolve quickly in water.

Can this treatment cure HIV?

No. There is currently no cure for HIV. The goal of this treatment is to keep the virus safely asleep and undetectable with fewer daily medicines.

What happens if the new treatment doesn't keep the virus controlled?

The care team regularly tests the child's blood. If the virus starts to become active again, the doctor will quickly switch the child back to a standard treatment.

Can we leave the study if we change our minds?

Yes. You can leave the study at any time for any reason. Your child will return to standard HIV treatment and their normal medical care will not be affected.

How to find out more

Alessandra Nardone

Alessandra.Nardone@pentafoundation.org +39 0498215447 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.