Ongoing, recruitingPhase II and Phase III (Integrated)Interventional

An Operationally Seamless Phase 2/3, Randomized, Active Controlled Study Evaluating the Safety and Efficacy of an Oral Weekly Regimen of GS-1720 in Combination with GS-4182 Versus Biktarvy in Treatment Naive People with HIV-1

This research study is for adults who have recently found out they have HIV-1 and haven't started treatment yet. It's looking at a new weekly pill combining two drugs, GS-1720 and GS-4182, and comparing it to a daily pill called Biktarvy, which is a common HIV-1 treatment. The study has two main parts: an earlier part (Phase 2) and a larger part (Phase 3). Researchers want to find out how well these treatments reduce the amount of HIV-1 in the blood to very low levels, making it 'undetectable'. They will also track any side effects and how the drugs work in the body. This study aims to find safer and more convenient ways to manage HIV-1.

At a glance

Status

Ongoing, recruiting

Phase

Phase II and Phase III (Integrated)

Sponsor

Gilead Sciences Inc.

Enrolment target

186

Start

12 Feb 2025

HIV-1 Infection

What is this study about?

This study is important because it's looking for new and potentially better ways to treat HIV-1. HIV-1 is a virus that attacks the body's immune system. While current treatments are very effective, researchers are always trying to find medicines that are easier to take (like a weekly pill instead of a daily one) or have fewer side effects.

Here, they are testing a new combination of two medicines, GS-1720 and GS-4182, which would be taken once a week. They are comparing it to Biktarvy, which is a highly effective medicine taken once a day. The main goal is to see how well these medicines can lower the amount of HIV-1 in a person's blood to a very low, undetectable level. This is sometimes called 'viral suppression' and it's a key goal of HIV treatment because it helps people stay healthy and prevents them from passing the virus to others.

The study has two phases that run together. In the earlier part (Phase 2), they look at the results after 24 weeks. In the main part (Phase 3), they check results after 48 weeks and even up to 96 weeks (about two years). They will also carefully watch for any side effects and understand how the new medicines behave in the body. This helps ensure that any new treatment is not only effective but also safe and easy for people to use.

Key takeaways

This study evaluates new, weekly HIV-1 treatment against current daily pill.
It's for adults recently diagnosed with HIV-1 and new to treatment.
Researchers are looking for effective viral control and safety.
Participation involves regular clinic visits and health checks.
You'll receive either the new weekly medicine or the daily Biktarvy.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you must be an adult, aged 18 or older. It is open to both men and women.

Crucially, you must have recently been diagnosed with HIV-1 and not have started any HIV treatment yet. This is important because the researchers want to see how well the new treatments work from the very beginning of someone's HIV journey.

There might be other specific health requirements for joining or reasons why you might not be able to participate, as determined by the study doctors. These will be discussed with you in detail if you are interested.

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 *not* started any treatment for HIV-1 yet?
Are you able to attend regular clinic appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given either the new weekly combination of GS-1720 and GS-4182 or the daily Biktarvy pill. You'll have regular visits to the clinic where doctors and nurses will check your health, take blood samples, and ask you about how you're feeling and any side effects you might be having. These appointments will help the study team understand how well the medication is working and if it's safe for you.

The study will last for a significant period. The main checks on how the treatment is working will happen at 24 weeks (for the early phase) and at 48 weeks (for the main study). Some participants will be followed for up to 96 weeks, which is almost two years. These regular checks are essential to gather all the necessary information about the medications. You'll be given all the study medication and care during this time.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit could be access to a new treatment that might be more convenient (like a weekly pill) or effective for you. However, there's also the chance that the new treatment might not work as well as existing options or could have side effects. Biktarvy, the daily pill used for comparison, is a well-known and effective treatment, but like all medications, it also has potential side effects. The study team will monitor your health very closely for any issues that arise. It's important to remember that you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (5)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Romania
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Unverified
Spain
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Unverified
Poland
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Unverified
Germany
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Unverified
Portugal

Common questions

What is HIV-1?

HIV-1 is a virus that can weaken your body's immune system, making it harder to fight off infections and illnesses. Untreated, it can lead to AIDS.

What does 'treatment-naive' mean?

This means you have HIV-1 but have not started any treatment for it yet.

What does 'undetectable' mean for HIV-1?

It means the amount of HIV-1 virus in your blood is so low that it cannot be measured by standard tests. This is a key goal of treatment, as it keeps you healthy and means you cannot pass the virus to others.

Will I know which treatment I am getting?

In some studies, you might not know if you're getting the new medicine or the comparison medicine. The study team can explain how this works for this particular trial.

Is Biktarvy a safe and effective treatment?

Yes, Biktarvy is a widely used and highly effective daily medication for HIV-1 that helps control the virus and keep people healthy.