A Phase 2b, Randomized, Active-Controlled, Double-Blind, Dose-Ranging Clinical Study to Evaluate a Switch to Islatravir (ISL) and MK-8507 Once-Weekly in Adults with HIV-1 Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Once-Daily
This study is looking at a new way to treat HIV-1. It's for adults who are currently managing their HIV well with a daily medication called Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF). The research will explore switching these participants to a new treatment combination, Islatravir (ISL) and MK-8507, which they would take once a week instead of daily. Doctors want to find out how safe this new weekly medicine is and if it works just as well as the daily tablet. This includes watching for any side effects people might experience.
At a glance
What is this study about?
This research study is about trying to find better ways to treat HIV-1, a virus that affects your immune system. Currently, many people with HIV take daily medication to keep the virus under control and stay healthy. One common and very effective daily medicine is called Bictegravir/Emtricitabine/Tenofovir Alafenamide, often shortened to BIC/FTC/TAF.
Doctors are always looking for treatments that are just as good, or even better, but perhaps easier to take. This particular study is testing a new combination of medicines, Islatravir and MK-8507, which could potentially be taken just once a week instead of every day. Imagine only having to remember your medication once a week! This could make a big difference for people living with HIV.
The main goal of this study is to see how safe this new weekly treatment is. Researchers will carefully watch for any side effects and how many people experience them. They will also look at how many people might need to stop the new treatment because of these effects. While not the main focus, they will also be checking to make sure the new treatment works well to keep the HIV virus under control.
Key takeaways
- This study explores a potential new once-weekly HIV treatment.
- It's for adults with HIV-1 who are already well-controlled on daily medication.
- The main focus is to check the safety and side effects of the new weekly drugs.
- Participants will receive either their current daily medication or the new weekly one.
- Taking part involves regular clinic visits and health monitoring.
Who may be eligible?
This study is for adults, aged 18 or older, who have HIV-1 infection. You can be male or female to take part.
Importantly, to be considered for this study, you must already be taking a specific daily HIV medication called Bictegravir/Emtricitabine/Tenofovir Alafenamide (also known as B/F/T or BIC/FTC/TAF). You must also be doing very well on this medication, meaning your HIV virus is 'suppressed' and controlled, with no detectable levels in your blood.
There will be other health checks and criteria that the study doctors will go through to make sure the study is a safe and suitable option for you. Not everyone who meets these basic requirements will be able to join.
- Are you 18 years old or older?
- Do you have HIV-1 infection?
- Are you currently taking BIC/FTC/TAF (Bictegravir/Emtricitabine/Tenofovir Alafenamide) daily?
- Is your HIV well-controlled (undetectable virus in your blood)?
- Are you willing to attend regular clinic visits and tests?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, you will continue to receive HIV medication, but it will be either your current daily medication or the new weekly combination, depending on which group you are assigned to. This will happen without you or your study doctor knowing which one you are taking for a period of time. You will have regular visits to the clinic where doctors and nurses will monitor your health, take blood and urine samples, and ask about any side effects you might be experiencing. These visits are important to make sure the new medication is safe and effective for you. The total duration of your participation in the study, including all follow-up, will be explained in detail by the study team.
Potential risks and benefits
Locations (1)
- —France
Common questions
What is HIV-1?
HIV-1 is a virus that can damage your immune system, making it harder for your body to fight off infections and diseases.
What does 'virologically suppressed' mean?
It means your HIV medication is working very well, and the amount of HIV virus in your blood is so low it can't be measured or detected by standard tests.
What is a 'double-blind' study?
In a double-blind study, neither you nor your study doctor will know which specific treatment you are receiving. This helps make the study results fairer and more accurate.
Will I have to pay to be in this study?
No, your study medication and all study-related visits and tests will be provided at no cost to you.
Will I still get my regular HIV care?
Yes, you will continue to receive good medical care for your HIV throughout your participation in the study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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