An open-label, roll-over study with rilpivirine in combination with a background regimen containing other antiretrovirals (ARVs) in human immunodeficiency virus type 1 (HIV-1) infected subjects who participated in rilpivirine pediatric studies.
This clinical trial is designed for people aged 18 and older living with HIV-1 who previously took part in a childhood study testing the medicine rilpivirine. Rilpivirine is an antiretroviral treatment that helps keep HIV under control by stopping the virus from copying itself. In this 'roll-over' study, participants continue taking rilpivirine as part of their daily HIV treatment plan. It is 'open-label', meaning both the participants and their medical teams know which medicine is being taken. The main purpose is to ensure that people who did well on rilpivirine in earlier studies can continue receiving it safely as adults. Taking part involves attending regular clinic check-ups, having routine blood tests to monitor viral levels and general health, and taking the medication as prescribed. Taking part is completely voluntary and will not affect standard NHS care.
At a glance
What is this study about?
Human immunodeficiency virus type 1 (HIV-1) attacks the immune system, making it harder for the body to fight off infections. While there is currently no cure, modern treatments called antiretrovirals can reduce the virus to undetectable levels in the blood. This allows people with HIV to live long, healthy lives and prevents the virus from being passed on to others. Treatment usually involves taking a combination of medicines every day.
Rilpivirine is an established antiretroviral medicine that was tested in younger people to find the right doses and check safety. When those earlier studies finish, patients still need reliable access to their medicine. This roll-over study provides a bridge, allowing participants who took rilpivirine in childhood trials to continue taking it now that they are adults, combined with their other standard HIV medicines.
By following participants as they grow older, researchers can learn more about how rilpivirine performs over several years. This helps doctors better understand the long-term safety, effectiveness, and tolerability of the drug as young people transition from paediatric care into adult healthcare services.
Key takeaways
- This study provides continued access to rilpivirine for adults who previously took part in childhood trials of the drug.
- It is open-label, meaning everyone knows they are taking rilpivirine alongside their standard HIV medicines.
- Participants must be 18 or older and living with HIV-1.
- Regular clinic visits and blood tests are required to check safety and treatment success.
- Participation is entirely voluntary and you can withdraw at any time.
Who may be eligible?
This trial is specifically for individuals aged 18 or older living with HIV-1 who previously completed or took part in a paediatric (childhood) clinical trial involving rilpivirine. Both men and women can join.
You will not be able to join if you did not participate in one of the specific earlier rilpivirine studies. Doctors will also check that your current HIV treatment is working well and that rilpivirine remains a safe and suitable option for your health.
Your study doctor will review your medical history and discuss whether continuing this treatment is the right choice for you before you decide to enrol.
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.
- I am aged 18 or older.
- I have been diagnosed with HIV-1.
- I previously took part in a paediatric (childhood) clinical study for rilpivirine.
- I am able to attend regular clinic check-ups and have routine blood tests.
- My doctor agrees that rilpivirine remains a safe treatment for me.
What does participation involve?
If you take part, you will continue taking rilpivirine, usually as a daily tablet with a meal, alongside your regular HIV medicines. You will need to attend scheduled clinic appointments so the medical team can monitor your health. These visits will include physical checks, reviews of any side effects, and routine blood tests to measure your CD4 cell count and viral load. The study will continue to support you until the medicine becomes routinely available through normal health services or until you and your doctor decide on a different treatment path.
Potential risks and benefits
Locations (1)
- —UnverifiedItaly
Common questions
What is a 'roll-over' study?
A roll-over study allows people who finished an earlier clinical trial to move directly into a new study to continue receiving their treatment without interruption.
What does 'open-label' mean?
Open-label means that there are no dummy treatments (placebos). You and your study doctor will both know exactly which medicine and dose you are taking.
Will taking part cure my HIV?
No, there is currently no cure for HIV. Rilpivirine helps keep the virus suppressed to undetectable levels so you stay healthy, but it does not remove the virus from your body.
Can I leave the study if I change my mind?
Yes. You are free to stop taking part at any point. Your normal healthcare team will support you in moving to another suitable HIV treatment.
Does it cost anything to take part?
No, the study medication and study-related tests are provided free of charge, and you may be able to claim back travel expenses for your visits.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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