A Phase IIIb, multi-center, non-randomized, parallel-group, open-label, hybrid type I study evaluating the efficacy, safety, implementation effectiveness, and patient-reported outcomes of oral dolutegravir/lamivudine once-daily as a first-line regimen followed by participant-determined optional switch to long-acting intramuscular cabotegravir plus rilpivirine every two months for the maintenance of virologic suppression in antiretroviral therapy naive adults living with HIV-1.
This research study is for adults with HIV-1 who are starting treatment for the first time. It's designed to compare different treatment approaches. Initially, all participants will take a daily tablet called Dovato. After some time, some individuals will have the option to switch to a different treatment, which involves injections given every two months (Cabotegravir plus Rilpivirine). The main goals are to see how quickly the daily tablet reduces the amount of virus in the body, how well the injectable treatment keeps the virus under control after a year, and if the treatments are safe. The study also explores how these treatments fit into people's lives and how they feel about their care.
At a glance
What is this study about?
This important study is designed for adults who have recently been diagnosed with HIV-1 and are starting their treatment journey for the very first time. The main aim is to understand the best ways to keep the HIV virus under control, making sure people stay healthy and well. We know that taking daily tablets can sometimes be challenging, so researchers are looking at options that might offer more flexibility.
The study begins with everyone taking a daily tablet called Dovato. This tablet contains two medicines (dolutegravir and lamivudine) and is a common starting point for HIV treatment. The researchers will closely watch how quickly this tablet reduces the amount of HIV in the blood to very low levels. Once the virus is under control with the daily tablet, some people in the study will have an interesting choice.
They can choose to continue with the daily Dovato tablet, or they can switch to a new treatment plan. This alternative involves receiving injections every two months, using medicines called cabotegravir and rilpivirine. The study wants to find out if these injections are just as good at keeping the virus at very low levels, if they are safe, and how people feel about this different way of taking their medication. This could offer a new, more convenient option for long-term HIV care.
Key takeaways
- This study evaluates new ways to treat HIV-1 for people starting treatment.
- It compares daily tablets with less frequent injections.
- The goal is to find effective, safe, and convenient treatment options.
- Participants will receive close medical monitoring.
- You have the choice to switch from tablets to injections if you meet criteria.
- It helps us understand long-term treatment satisfaction and effectiveness.
Who may be eligible?
This study is looking for adult volunteers, 18 years old or older, who have been diagnosed with HIV-1.
To join, you must not have received any HIV treatment before. The medical team will check other health details to make sure the study is a safe and suitable option for you.
There might be other specific health requirements or conditions that would prevent someone from taking part, but the study team will discuss all of these with you in detail.
- Are you 18 years old or older?
- Have you been diagnosed with HIV-1?
- Have you never taken any HIV treatment before?
- Are you willing to attend regular clinic visits and follow study instructions?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you'll start by taking the Dovato tablet once a day. You'll have regular hospital visits for blood tests and health checks. These visits will help the study team see how well the treatment is working and if you're experiencing any side effects. After a certain period, if you're doing well and the virus is controlled, you'll have the option to switch to the injectable treatment (Cabotegravir and Rilpivirine), which means you'd receive injections every two months instead of daily tablets. Throughout the study, whether you stay on tablets or switch to injections, you'll have ongoing check-ups to monitor your health and the effectiveness of the treatment. The total length of the study for each participant will be determined by how long the researchers need to gather all the necessary information, but regular check-ups will be part of the care.
Potential risks and benefits
Locations (4)
- —Italy
- —France
- —Spain
- —Germany
Common questions
What is HIV-1?
HIV-1 is the most common type of Human Immunodeficiency Virus, which affects the body's immune system.
What do 'first-line regimen' and 'antiretroviral therapy naive' mean?
It means this study is for people starting HIV treatment for the very first time and haven't taken HIV medicines before.
What is 'virologic suppression'?
This means that the amount of HIV virus in your blood has been reduced to a very low, almost undetectable level by the treatment.
Are the injections painful?
Injections can cause some temporary discomfort at the site, but your healthcare team will do their best to make it as comfortable as possible.
What happens if a treatment doesn't work for me?
Your health will be closely monitored, and if a treatment isn't working or causing problems, your doctors will discuss other treatment options with you immediately.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.