AuthorisedPhase 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 Virologically Suppressed People With HIV-1

This study is looking at a new way to treat HIV, using a pill taken once a week instead of daily. It's for adults whose HIV is already well-managed with their current medication. Researchers want to compare the safety and effectiveness of this new weekly pill combination (GS-1720 with GS-4182) against a common daily treatment called Biktarvy. The main aim is to see if the new weekly treatment can keep the amount of HIV in the blood very low, just as well as the daily treatment. They will also look at any side effects and how the new treatment affects the immune system.

At a glance

Status

Authorised

Phase

Phase II and Phase III (Integrated)

Sponsor

Gilead Sciences Inc.

Enrolment target

Start

13 Feb 2025

HIV-1 Infection

What is this study about?

This research study is about finding better ways to manage HIV. HIV treatments have come a long way, but most people still need to take pills every day. This study is testing a new treatment that you would only need to take once a week. Imagine having to take your medication only once a week instead of every single day – it could make managing HIV much easier for many people.

The study involves two new medications, GS-1720 and GS-4182, which will be given together as a weekly treatment. These will be compared to a well-known daily HIV medication called Biktarvy, which has been proven to work well. The main goal is to see if this new weekly treatment is just as good at keeping the amount of HIV virus in the blood very low (which means the treatment is working) and if it's safe to use.

This study will help us understand if a weekly HIV treatment can be a good option for people whose HIV is already under control. Finding simpler ways to take medication can make a big difference to people's lives, making it easier to stick to their treatment plan and live well with HIV.

Key takeaways

This study tests a new weekly HIV pill.
It's for adults whose HIV is already well-controlled.
Compares the new weekly pill to a standard daily treatment (Biktarvy).
Aims to check safety and how well it keeps HIV levels low.
Participation involves regular clinic visits for blood tests and health checks.
Could offer a simpler way to manage HIV in the future.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. Both men and women are welcome to take part.

Crucially, your HIV needs to be well controlled already. This means that your current HIV treatment should be working effectively, and the amount of HIV virus in your blood should be very low.

There might be other specific health checks or conditions that determine if you can join, which the study team will discuss with you. These are put in place to ensure your safety and that the study results are clear.

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?
Is your HIV already being managed well by your current treatment?
Is the amount of HIV virus in your blood currently very low?
Are you able to attend regular clinic appointments for about 1 to 2 years?

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 pill combination (GS-1720 with GS-4182) or the daily Biktarvy medication. This decision will be made randomly, like flipping a coin.

You will have regular visits to the clinic over a period of about 1 to 2 years. During these visits, the study team will check your health, take blood samples to measure your HIV levels and immune cells, and ask about any side effects you might be experiencing. These checks are important to see how well the treatment is working and to make sure it's safe for you. The total duration of your participation in the study could be up to 96 weeks (about 1 year and 10 months).

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as access to a new, potentially simpler HIV treatment before it's widely available. You'll also receive careful monitoring of your health by medical professionals. However, there are also potential risks; you might experience side effects from the study medication, which the team will explain in detail. The new treatment might also not work as well for you as your current medication. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

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

—
Unverified
France
—
Unverified
Germany
—
Unverified
Poland
—
Unverified
Sweden
—
Unverified
Spain
—
Unverified
Italy

Common questions

What is HIV-1 RNA?

HIV-1 RNA is a way we measure how much of the HIV virus is in your blood. A low number, especially below 50, means the treatment is working well.

What does 'virologically suppressed' mean?

This means that the HIV virus in your blood is at a very low level because your current treatment is working effectively to control it.

What's the difference between Phase 2 and Phase 3?

Phase 2 studies mainly look at safety and if the treatment works. Phase 3 studies involve more people and compare the new treatment to existing ones to confirm safety and effectiveness on a larger scale.

What is Biktarvy?

Biktarvy is a common and effective daily medication that many people with HIV already take to keep the virus under control.

Will I know if I'm getting the new weekly pill or Biktarvy?

No, it's a 'blinded' study, meaning neither you nor your study doctor will know which treatment you are receiving. This helps make the study results fair.