Active not recruitingPHASE2INTERVENTIONAL

A Study of Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection

This study is looking at a new combination of medicines for adults living with HIV-1 whose virus is currently well-controlled by their existing treatment. The new medicines are called teropavimab, zinlirvimab, and lenacapavir. These are being studied to see how safe they are, if they are well-tolerated, and how effective they are. The main goal is to see if switching to this new combination works as well as, or better than, staying on their current daily HIV medication. Researchers will check if the amount of virus in the blood stays very low after 26 weeks. It's a Phase 2 study, which means it's still in the earlier stages of human testing.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Gilead Sciences

Enrolment target

Start

15 May 2023

Estimated completion

01 Dec 2030

HIV-1 Infection

Results

Results from this study

Posted July 2025

Results have been published for this study.

Primary outcome

Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) ≥ 50 Copies/mL at Week 26 as Determined by the United States Food and Drug Administration (US FDA)-Defined Snapshot Algorithm

Percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 26 was analyzed using US FDA-defined snapshot algorithm, which defines a participant's virologic outcome and included participants a) who had last available on-treatment HIV-1 RNA ≥ 50 copies/mL in the Week 26 analysis window; or b) who did not have on-treatment HIV-1 RNA data in the Week 26 analysis window and i) discontinued study drug prior to or in the Week 26 analysis window due to lack of efficacy, or ii) discontinued study drug prior to or in the Week 26 analysis window due to adverse event (AE) or death and had last available on-treatment HIV-1 RNA ≥ 50 copies/mL, or iii) discontinued study drug prior to or in the Week 26 analysis window due to reasons other than AE, death, or lack of efficacy and had the last available on-treatment HIV-1 RNA ≥ 50 copies/mL. Clopper-Pearson exact method was used to calculate the 95% confidence interval (CI) for the outcome measure of each treatment. Percentages were rounded off.

Full results on the registry

What is this study about?

If you are an adult living with HIV-1 and your current treatment is successfully keeping the virus under control, you might be interested in a new research study. This study is testing a new way of treating HIV, using a combination of medicines called teropavimab, zinlirvimab, and lenacapavir. These drugs work differently from some standard HIV medications. The main reason for this study is to explore if this new combination could be a good treatment option for maintaining very low levels of the HIV virus in the body.

The study aims to compare this new treatment combination with the standard daily HIV medication that many people are already taking. Researchers want to understand if people who switch to the new combination continue to have their virus well-controlled, similar to those who stay on their current medication. They will be carefully checking how safe the new drugs are, if people have side effects, and how well the treatment keeps the virus at bay.

This is a 'Phase 2' study, which means it's an important step in developing new medicines. It's not yet known if these new drugs will become a widely available treatment, but studies like these help us find new and better ways to manage HIV and improve the health of people living with the condition.

Key takeaways

This study is for adults with HIV-1 whose virus is already under control.
It tests a new combination of medicines: teropavimab, zinlirvimab, and lenacapavir.
The goal is to see if this new combination is safe and keeps the virus suppressed as effectively as current treatments.
Participation involves regular clinic visits and health checks over about one year.
You might receive the new drugs or continue your current HIV medication, decided by chance.
You can stop participating in the study at any time.

Who may be eligible?

To join this study, you need to be an adult between 18 and 65 years old and have HIV-1. A key requirement is that your current HIV treatment must be working very well, meaning the amount of virus in your blood has been undetectable (or very low) for at least the past year. You also need to have a healthy immune system, shown by a good CD4 cell count.

There are also some important things that would prevent you from joining. For example, if you have certain other serious health conditions like active Hepatitis B or C, or if you have a history of certain serious HIV-related illnesses. The researchers will also check your HIV virus to make sure it's likely to respond to the new study drugs.

It's important to remember that these are just some of the main points. The study team will review your full medical history to make sure the study is a safe and suitable option for 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 between 18 and 65 years old?
Have you been taking stable HIV medication for at least one year?
Has your HIV virus consistently been undetectable or very low for at least the past year?
Do you have a healthy immune system (good CD4 count)?
Do you have Hepatitis B or C or a history of serious HIV-related illnesses? (If yes to these, you likely can't join.)

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would either switch to the new study medication called lenacapavir, teropavimab, and zinlirvimab, or you would continue taking your current HIV medication. The study team will decide which group you are in by chance (this is called 'randomization'). Initially, there were plans for two different ways to give the new drugs, but one of these options was removed early on.

You would be in the study for at least 52 weeks (about one year). During this time, you would have regular visits to the clinic for health checks, blood tests, and to get your medication. These tests help the doctors keep a close eye on how you're doing, how the medication is working, and to check for any side effects. After the first year, there might be an option for some participants to continue on the new study medication in an extension part of the study.

Potential risks and benefits

Taking part in this study could offer some potential benefits, such as receiving a new and potentially effective HIV treatment that might work differently from current options. You would also receive close medical attention and monitoring throughout the study. However, like all medications, the study drugs could have side effects, and some might be serious. It's also possible that the new treatment might not work as well for you as your current medication. You are free to withdraw from the study at any time and for any reason, without it affecting your usual medical care.

Locations (34)

Ruane Clinical Research Group, Inc.
Verified postcode
Los Angeles, United States
Mills Clinical Research
Verified postcode
Los Angeles, United States
UC San Diego (UCSD) AntiViral Research Center (AVRC)
Verified postcode
San Diego, United States
Optimus Medical Group
Verified postcode
San Francisco, United States
University of Colorado Clinical and Translational Research Center
Verified postcode
Aurora, United States
Yale University; School of Medicine; AIDS Program
Verified postcode
New Haven, United States
Georgetown University Medical Center
Verified postcode
Washington D.C., United States
Midland Florida Clinical Research Center, LLC
Verified postcode
DeLand, United States
Can Community Health Care
Verified postcode
Fort Lauderdale, United States
Midway Immunology and Research Center
Verified postcode
Ft. Pierce, United States
Orlando Immunology Center
Verified postcode
Orlando, United States
Triple O Research Institute, P.A.
Verified postcode
West Palm Beach, United States

Common questions

What is HIV-1 infection?

HIV-1 is the most common type of Human Immunodeficiency Virus, which attacks the body's immune system. Treatments help manage the virus and keep people healthy.

What does 'virologically suppressed' mean?

It means your current HIV medication is working well, and the amount of HIV virus in your blood is very low or undetectable.

What are 'broadly neutralizing antibodies'?

These are special proteins that your body (or engineered in a lab) can make to fight off many different types of viruses, including HIV.

What are the new medicines being tested?

The study medicines are teropavimab, zinlirvimab (which are broadly neutralizing antibodies), and lenacapavir (which is a capsid inhibitor).

What is a Phase 2 study?

Phase 2 studies are an important step where new medicines are tested in a small group of people to see if they are safe, how well they work, and what dosage is best.