Active not recruitingPHASE2, PHASE3INTERVENTIONAL

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

This research study aims to find out if switching to an investigational two-drug combination, bictegravir (BIC) and lenacapavir (LEN), is a good option for people living with HIV-1. Participants currently take a complex HIV medication routine, perhaps because of past drug resistance or difficulties with simpler treatments. The study will compare the new BIC/LEN combination, which will eventually be available as a single pill, against their existing treatment. By doing this, researchers hope to see if the new combination can effectively manage HIV while potentially offering a simpler and more convenient treatment plan for those who need it.

At a glance

Status

Active not recruiting

Phase

PHASE2, PHASE3

Sponsor

Gilead Sciences

Enrolment target

689

Start

16 Aug 2022

Estimated completion

01 Jul 2028

HIV-1-infection

What is this study about?

This clinical trial is designed for people who have HIV-1 and are doing well on their current medication, meaning their viral load is consistently very low. However, their current treatment plan might be complicated. This could be because of previous challenges like the virus becoming resistant to certain drugs, or if they've found simpler treatments difficult to tolerate, or if they have other health conditions that make single-pill treatments unsuitable.

The main goal of this study is to look at a new combination of two drugs, called bictegravir and lenacapavir. These drugs work in different ways to keep HIV under control. Researchers want to see if switching to this new combination is as effective as their current treatment, but potentially simpler. Eventually, these two drugs might be combined into a single pill, making daily treatment much easier for people who are currently taking multiple pills or have a more complex schedule.

By comparing the new drug combination with current complex treatments, the researchers hope to understand if it can offer an easier way to manage HIV for people who need it. This could lead to new, more convenient treatment options in the future.

Key takeaways

This study is for adults with well-controlled HIV-1 on a complex medication plan.
It tests a new two-drug combination (bictegravir and lenacapavir) against current complex treatments.
The goal is to find a simpler, effective treatment option.
Participation involves regular clinic visits and health checks.
You can stop participating at any time.
The study aims to improve future HIV treatment convenience.

Who may be eligible?

This study is looking for adults aged 18 and over who have HIV-1. To be considered, your HIV-1 infection must be well-controlled, meaning the amount of virus in your blood has been consistently very low for at least the past year.

You also need to be taking a complex HIV medication regimen right now. This means you might be taking several pills a day, taking medication more than once a day, or taking injections in addition to oral medication. This could be because your virus has developed resistance to other drugs in the past, or because you can't take simpler, single-pill treatments for other reasons. It's important that you haven't taken lenacapavir before and that your virus isn't expected to be resistant to bictegravir. Your kidneys should also be working well enough to take part.

There are also a few reasons why you might not be able to join. For example, if you have an active tuberculosis infection or ongoing chronic hepatitis B. The study team 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 an adult (18 years or older) with HIV-1?
Has your HIV been well-controlled (undetectable viral load) for at least the past year?
Are you currently taking multiple HIV pills, or taking medication more than once a day, or getting injections for your HIV?
Have you never taken lenacapavir before?
Is your kidney function generally good?
Do you not have active tuberculosis or chronic hepatitis B?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned to either receive the new bictegravir/lenacapavir treatment or continue with your current HIV treatment. This decision is made randomly, like flipping a coin. You will have regular visits to the clinic where you'll have blood tests, health checks, and discussions about how you're feeling and any side effects you might be having. These visits will help the doctors monitor your health and the effectiveness of your medication.

The study involves different phases. Initially, it will compare the new combination with your current therapy, and then in a later stage, it will look at a fixed-dose combination (a single pill containing both drugs) against your current treatment. The total duration of your participation, including follow-up, will be explained in detail by the study team, but clinical trials typically involve several months to over a year of regular monitoring.

Potential risks and benefits

Taking part in this study could potentially offer you a simpler and more convenient way to manage your HIV, especially if your current treatment is complex. However, like all medications, the study drugs might cause side effects, and the new combination might not work as well for you as your current treatment. The study team will carefully monitor your health throughout the trial and explain all known or potential risks. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (94)

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
University of California San Diego (UCSD)
Verified postcode
San Diego, United States
Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center
Verified postcode
Torrance, United States
The Men's Health Foundation
Verified postcode
West Hollywood, United States
Denver Health Medical Center
Verified postcode
Denver, United States
Yale University; School of Medicine; AIDS Program
Verified postcode
New Haven, United States
Midland Florida Clinical Research Center, LLC
Verified postcode
DeLand, United States
Therafirst Medical Centers
Verified postcode
Fort Lauderdale, United States

Common questions

What is HIV-1 RNA?

HIV-1 RNA is a measure of how much of the HIV virus is in your blood. A level of less than 50 copies/mL means the virus is very well controlled, or 'undetectable'.

What does 'complex antiretroviral (ARV) regimen' mean?

It means your current HIV medication involves taking multiple pills, possibly more than once a day, or even injections, often because simpler, single-pill options aren't suitable for you.

What are bictegravir and lenacapavir?

They are two different medicines that work in different ways to control HIV. In this study, they are being tested together, eventually aiming for a simple, single-pill combination.

What is viral resistance?

Viral resistance means the HIV virus in your body has changed in a way that makes some HIV medicines less effective or no longer work.

Can I still join if I have other health conditions?

The study has specific health requirements, like good kidney function. If you have other health conditions, the study team will review them to determine if you can safely participate.