A Phase 3b, multicenter, single-arm, open-label study evaluating the efficacy, safety, and tolerability of switching to DTG/3TC single tablet regimen administered once daily from a bictegravir/emtricitabine/tenofovir alafenamide single tablet regimen in people living with HIV of at least 50 years of age who are virologically suppressed
This research study is for people living with HIV who are aged 50 or over. Currently, they should be taking a medicine called Biktarvy and have their HIV under control. The study aims to find out what happens if they switch to a different HIV medicine called Dovato. Researchers will check if Dovato is as effective at keeping the virus at very low levels (which is called 'virologically suppressed'). They will also carefully monitor any side effects and how people feel about taking the new medication. This helps doctors understand if Dovato is a good alternative treatment option for people in this age group, potentially simplifying their daily medicine routine while maintaining their health.
At a glance
What is this study about?
This study is looking at a new way to manage HIV for people aged 50 and over. If you're living with HIV, you likely take daily medication to keep the virus under control. This study focuses on two specific medications: Biktarvy and Dovato. Currently, you might be taking Biktarvy and doing well, meaning the virus is at very low levels in your blood. This study wants to see what happens if you switch to Dovato instead.
The main goal is to check if Dovato works just as well as Biktarvy in keeping your HIV under control. Researchers will be looking for how many people who switch still have very low levels of HIV in their blood after a certain amount of time. They will also carefully watch for any side effects and how you feel about taking Dovato, to make sure it's safe and well-tolerated. This helps doctors decide if Dovato could be a good choice for older adults living with HIV.
Understanding how different treatments work for various groups of people is very important. This study helps build knowledge about HIV care specifically for older adults, aiming to improve treatment options and quality of life. By participating, you could help doctors learn more about managing HIV effectively for others in the future.
Key takeaways
- This study is for people aged 50 or older living with HIV.
- It checks if switching from Biktarvy to Dovato is safe and effective.
- You would take Dovato once daily and have regular check-ups.
- Participation involves about two years of follow-up.
- Your health will be closely monitored by the study team.
- You can stop participating at any time.
Who may be eligible?
This study is for adults who are living with HIV. To take part, you need to be at least 50 years old. Both men and women can join.
Crucially, you must already be taking a specific HIV medication called Biktarvy, and your HIV should be well-controlled. This means the amount of virus in your blood (your viral load) should be very low.
There might be other specific health requirements or conditions that you would need to meet to ensure the study is safe and appropriate for you. The study team will explain these in full detail.
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.
- Are you 50 years old or older?
- Do you have HIV?
- Are you currently taking Biktarvy for your HIV?
- Is your HIV well-controlled (meaning your viral load is very low)?
- Are you generally feeling well and stable on your current treatment?
What does participation involve?
If you decide to take part, you would switch from your current HIV medication, Biktarvy, to Dovato. You would take Dovato once a day. Throughout the study, you'd have regular visits to the clinic. During these visits, the study team would take blood samples to check your HIV levels, your immune cell counts (CD4 cells), and overall health. They would also ask you how you're feeling and if you've had any side effects. These check-ups would happen at specific times, including at 24 weeks, 48 weeks, and 96 weeks after you start the new medication. The total length of your participation in the study would be about 96 weeks, which is roughly two years.
Potential risks and benefits
Locations (8)
- —UnverifiedBelgium
- —UnverifiedItaly
- —UnverifiedPortugal
- —UnverifiedAustria
- —UnverifiedSpain
- —UnverifiedGermany
- —UnverifiedFrance
- —UnverifiedNetherlands
Common questions
What is Dovato?
Dovato is a film-coated tablet that contains two different medicines which help to control HIV.
What is Biktarvy?
Biktarvy is another film-coated tablet that contains three different medicines to treat HIV.
What does 'virologically suppressed' mean?
This means that the amount of HIV in your blood is so low that it's almost undetectable. Your current medication is successfully keeping the virus under control.
Why is this study only for people aged 50 or over?
The study aims to gather specific information about how this medication works for older individuals living with HIV, as their bodies may react differently to treatments.
What are CD4 cells?
CD4 cells are special immune cells that HIV attacks. Doctors check their count to see how well your immune system is working.
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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