DTG/3TC Fixed Dose Formulations for the Maintenance of Virological Suppression in Children With HIV Infection Aged 2 to <15 Years Old
This research is investigating a new, simpler treatment for children and young people aged 2 to 15 who are living with HIV. Instead of the usual three anti-HIV medicines, this study looks at a two-medicine combination: dolutegravir and lamivudine. The main goal is to find out if this two-drug treatment is as safe and works just as well as the standard three-drug treatments currently used. Participants will be split into two groups – one continuing their current treatment and the other trying the new two-drug combination. The study will carefully check how well the medicines work and if there are any side effects.
At a glance
What is this study about?
This study is about making HIV treatment simpler for children and young people. Currently, many children living with HIV take three different medicines to manage their condition. This study wants to see if a combination of just two medicines, called dolutegravir and lamivudine, can be just as good.
The researchers want to make sure that this two-drug option is safe and keeps the virus under control just as effectively as the current three-drug treatments. If it is, it could mean fewer pills and potentially easier treatment for many young people with HIV. It's important to find ways to make managing HIV as straightforward as possible for children as they grow.
Taking part in a study like this helps doctors learn more about the best ways to treat HIV, which can improve care for all children with the condition in the future. It’s a very important step towards better, more manageable treatments.
Key takeaways
- This study explores a simpler, two-drug HIV treatment for children aged 2-15.
- It aims to see if two medicines are as safe and effective as three medicines.
- Participants will receive regular medical check-ups and blood tests.
- The study lasts for at least 96 weeks (about 22 months).
- It could lead to easier treatment options for children with HIV.
- A parent or guardian must give permission for the child to participate.
Who may be eligible?
This study is looking for children and young people aged 2 to under 15 years old who are living with HIV. They need to have been successfully managing their HIV with their current medicines for at least the past six months, meaning the virus is well under control. They also need to weigh at least 6 kilograms.
Girls who have started their periods would need a negative pregnancy test to join and, if sexually active, would need to use effective contraception. A parent or legal guardian must agree for the child to participate and follow the study rules. If a child is old enough to understand, they will also be asked if they want to take part.
Children cannot join if they've recently had their HIV treatment changed because it wasn't working, or if they have certain past reactions or allergies to the study drugs. Those being treated for tuberculosis would need to finish that treatment first. Also, if they take other medicines that would seriously interfere with the study drugs, they might not be able to join.
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.
- Is your child between 2 and under 15 years old?
- Does your child have HIV and is their virus well controlled by current medicines for at least the last 6 months?
- Does your child weigh at least 6 kilograms?
- Is your child not currently being treated for active tuberculosis?
- Does your child feel comfortable taking medicine that contains dolutegravir or lamivudine?
What does participation involve?
If you join this study, you'll be put into one of two groups by chance, like flipping a coin. One group will continue with their usual HIV medicines. The other group will switch to the new two-medicine combination (dolutegravir and lamivudine). Depending on their weight, children in this second group will take either one tablet or a few small 'dispersible' tablets (which can be dissolved) once a day.
All children in the study will have regular check-ups at the clinic, similar to their normal HIV care appointments. These visits will include blood tests to make sure the medicine is safe and working well. Sometimes, children and their carers will be asked to answer questions about how they feel and how they're managing their medicines. Everyone will be followed for at least 96 weeks (about 1 year and 10 months). After this, children receiving the new two-drug treatment may continue to be monitored for a longer period if doctors think it's still suitable and they can't get the medicine elsewhere.
Potential risks and benefits
Locations (14)
- King Edward VIII HospitalVerified postcodeDurban, South Africa
- PHRU KlerksdorpVerified postcodeKlerksdorp, South Africa
- PHRUVerified postcodeSoweto, South Africa
- Hospital Universitario 12 de OctubreVerified postcodeMadrid, Spain
- Prapokklao HospitalVerified postcodeChanthaburi, Thailand
- Nakornping HospitalVerified postcodeChiang Mai, Thailand
- Chiangrai Prachanukroh HospitalVerified postcodeChiang Rai, Thailand
- Khon Kaen HospitalVerified postcodeKhon Kaen, Thailand
- BaylorVerified postcodeKampala, Uganda
- Joint Clinical Research CentreVerified postcodeKampala, Uganda
- MUJHUVerified postcodeKampala, Uganda
- Birmingham Heartlands HospitalVerified postcodeBirmingham, United Kingdom
Common questions
What is HIV?
HIV is a virus that attacks the body's immune system, which helps fight off infections. Medicines help keep the virus under control.
What are 'anti-HIV medicines'?
These are special drugs that help manage HIV, stopping the virus from making copies of itself and damaging the immune system.
What does 'virologically suppressed' mean?
It means the HIV virus in the body is at a very low level and is well controlled by the medicines.
Will I know which treatment group I'm in?
Yes, unlike some studies, you and your doctor will know whether you are continuing your usual treatment or switching to the new two-drug combination.
How long will the study last?
Every child in the main part of the study will be followed for at least 96 weeks, which is roughly one year and ten months.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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