Active not recruitingPHASE3INTERVENTIONAL

Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy

This study is for people living with HIV-1 who are currently doing well on a medication called Biktarvy. Researchers want to see what happens when these patients switch to a different combination of medicines called bictegravir/lenacapavir. The main goal is to find out if this new treatment works comparably to Biktarvy in keeping the HIV virus under control. This is a Phase 3 study, meaning it's a key stage in testing potential new treatments. It compares switching to the new drugs versus continuing on the current Biktarvy treatment, ultimately aiming to understand the effectiveness of the new drug combination.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Gilead Sciences

Enrolment target

577

Start

25 Mar 2024

Estimated completion

01 Dec 2029

HIV-1-infection

What is this study about?

This study is for adults living with HIV-1 who are currently managing their condition successfully. If you're on a medication called Biktarvy and your HIV virus levels are very low or undetectable, this study might be for you. Researchers want to explore if a different combination of drugs, called bictegravir and lenacapavir, could be a suitable alternative. The aim is to see if switching to this new combination works just as well as staying on Biktarvy in keeping the HIV under control.

Think of it like this: if you're happy with your current mobile phone but a new model comes out with potentially improved features, you might wonder if switching would be beneficial. In this study, the 'new model' is the bictegravir/lenacapavir combination. Researchers need to test it carefully to make sure it's safe and effective for people who are already doing well on their current treatment.

The main question this study hopes to answer is about how effective it would be to switch to the new BIC/LEN tablets compared to continuing with the Biktarvy tablets. This is important for finding new options and improving care for people living with HIV-1.

Key takeaways

Targets people with HIV-1 who are stable on Biktarvy.
Compares switching to bictegravir/lenacapavir versus continuing Biktarvy.
Aims to see if the new treatment works just as well.
Participation involves regular clinic visits and health checks.
You won't know which treatment you're getting until the study ends.
You can stop participating at any time.

Who may be eligible?

To join this study, you must be 18 years or older and currently taking Biktarvy for your HIV-1. You need to have been on Biktarvy for at least 6 months, and your HIV virus levels must be consistently low or undetectable during this time, including recent tests.

It's very important that your body doesn't show any signs of resistance to the medicines involved in the study, including bictegravir or tenofovir alafenamide. Also, your kidney function needs to be within a healthy range for you to take part.

There are also reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, have active serious infections like tuberculosis, or have certain types of hepatitis B. You also can't have previously taken lenacapavir, one of the new drugs being tested, or have severe allergies to any of the study medications.

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 or older?
Are you currently taking Biktarvy for HIV-1?
Have you been on Biktarvy for at least 6 months?
Are your HIV virus levels consistently undetectable or very low?
Do you have good kidney function?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive either the new combination of drugs (bictegravir/lenacapavir) or continue with your current Biktarvy treatment. It's a 'blinded' study, meaning neither you nor your study doctor will know which treatment you are receiving until the study is over.

You'll have regular visits to the clinic for check-ups, blood tests, and to make sure the medication is working well and you're not having any problems. The study duration isn't specified here, but clinical trials usually involve several months to over a year of follow-up care and monitoring. All medicines provided during the study are free of charge.

Potential risks and benefits

Taking part in a study like this might offer benefits, such as gaining access to a new potential treatment option and contributing to medical knowledge that could help others with HIV in the future. However, there are potential risks, including side effects from the medications, or that the new treatment might not work as well for you as your current one. All medications have potential side effects, and your study team will explain these in detail. Remember, your participation is completely voluntary, and you can withdraw from the study at any time without affecting your medical care.

Locations (104)

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

Pueblo Family Physicians
Verified postcode
Phoenix, United States
Be Well Medical Center
Verified postcode
Berkeley, United States
Pacific Oaks Medical Group
Verified postcode
Beverly Hills, United States
Ruane Clinical Research Group Inc.
Verified postcode
Los Angeles, United States
Alta Bates Summit Medical Center, Summit Campus, East Bay Advanced Care
Verified postcode
Oakland, United States
BIOS Clinical Research
Verified postcode
Palm Springs, United States
UCSD Anti Viral Research Centre (AVRC)
Verified postcode
San Diego, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Verified postcode
Torrance, United States
Mills Clinical Research
Verified postcode
West Hollywood, United States
Public Health Institute at Denver Health
Verified postcode
Denver, United States
Yale University School of Medicine (study visits)
Verified postcode
New Haven, United States
Midland Florida Infectious Diseases Specialists, PL - Orange City
Verified postcode
DeLand, United States

Common questions

What is HIV-1?

HIV-1 is a virus that attacks the body's immune system, making it harder to fight off infections and diseases.

What does 'virologically suppressed' mean?

It means the amount of HIV virus in your blood is very low, often too low to be detected by standard tests, thanks to your current medication.

Will I know if I'm getting the new drug or staying on Biktarvy?

No, this is a blinded study, meaning neither you nor your doctor will know which treatment you are receiving until the study is finished. This helps ensure fair results.

What if my HIV treatment stops working during the study?

Your doctors will monitor you closely. If your treatment isn't working as well as it should, they will make sure you receive the best care, which might include leaving the study and switching to a different established treatment.

Is a Phase 3 study safe?

Phase 3 studies are a later stage of drug development. The treatments have already been tested in earlier phases for safety and effectiveness, but it's still possible for new side effects to emerge. Patient safety is always the top priority.