A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy
This research study is for adults recently diagnosed with HIV-1 who haven't started treatment yet. It aims to compare two different types of daily pill treatments: one has two drugs (dolutegravir and lamivudine), and the other has three drugs (bictegravir, emtricitabine, and tenofovir alafenamide). The main goal is to find out which treatment is better at controlling the virus, if there are any differences in side effects, and how patients feel about each treatment, making sure it's easy to take. This vital work helps doctors understand the best ways to care for people living with HIV.
At a glance
What is this study about?
This study is a really important piece of research looking into different ways to treat HIV for adults who've just been diagnosed and haven't taken any HIV medication before. Doctors are always trying to find the best treatments that are not only very effective at controlling the virus but also have the fewest side effects and are easy for people to take regularly.
The study compares two main treatment options. One is a daily pill that contains two different medicines, dolutegravir and lamivudine. The other is also a daily pill but contains three different medicines: bictegravir, emtricitabine, and tenofovir alafenamide. Both combinations are known to be effective, but this study wants to see if one combination offers clearer benefits over the other, whether that's in how well it works, how safe it is, or how it affects a person's daily life.
By taking part, you would be helping doctors understand which of these modern HIV treatments might be the best first choice for people. This kind of research is vital for improving care and helping people with HIV live long, healthy lives.
Key takeaways
- Compares two vs. three-drug daily HIV treatments.
- For newly diagnosed adults who haven't taken HIV meds before.
- Aims to find out which treatment is safer and works better.
- Involves regular clinic visits and health checks.
- Helps improve future HIV care for everyone.
Who may be eligible?
This study is looking for adults aged 18 or over who have recently been diagnosed with HIV-1 and have never taken any HIV-1 medication before. It's really important that you understand what the study involves and are happy to give your permission to take part. If you live in France, you'll also need to be part of a social security system.
There are also some reasons why you might not be able to join. For example, if you are pregnant, planning to become pregnant, or breastfeeding, this study would not be suitable for you. Also, if you have certain other serious health problems or allergies to the study medications, you won't be able to participate. The study doctor will check all these details carefully with you.
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 18 years old or older?
- Have you been diagnosed with HIV-1?
- Have you *never* taken any HIV medication before?
- Are you *not* pregnant, planning to be pregnant, or breastfeeding?
What does participation involve?
If you decide to join this study, you'll be given one of the two types of daily HIV medication to take. You'll have regular visits to the clinic so the study team can monitor your health, check how the medication is working, and look for any potential side effects. These visits will involve blood tests and discussions about how you're feeling. They'll also ask you questions about your day-to-day life and experiences with the treatment. The total length of your participation in the study will be discussed with you by the research team.
Potential risks and benefits
Locations (64)
- GSK Investigational SiteUnverifiedCiudad Autonoma de Buenos Aire, Argentina
- GSK Investigational SiteVerified postcodeCórdoba, Argentina
- GSK Investigational SiteVerified postcodeAntwerp, Belgium
- GSK Investigational SiteVerified postcodeBrussels, Belgium
- GSK Investigational SiteVerified postcodeGhent, Belgium
- GSK Investigational SiteVerified postcodeHvidovre, Denmark
- GSK Investigational SiteVerified postcodeBordeaux, France
- GSK Investigational SiteVerified postcodeBordeaux, France
- GSK Investigational SiteVerified postcodeLyon, France
- GSK Investigational SiteVerified postcodeMontpellier, France
- GSK Investigational SiteVerified postcodeNice, France
- GSK Investigational SiteVerified postcodeNîmes, France
Common questions
What is HIV-1?
HIV-1 is the most common type of Human Immunodeficiency Virus, which affects the body’s ability to fight off infections.
What does 'antiretroviral-naïve' mean?
It means you have an HIV diagnosis but haven't started taking any medication for HIV yet.
Are the study drugs already approved?
The drugs being studied are already approved and commonly used in HIV treatment, but this study compares them in new ways or combinations.
Will I know which treatment I'm getting?
Often in studies like this, patients are randomly assigned to a treatment and may not know which one they are receiving to ensure fair comparison. The study team will explain how this works.
Who is paying for this study?
The study is sponsored by a pharmaceutical company or research organisation, who fund the research to advance medical knowledge.
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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