Active not recruitingPHASE3INTERVENTIONAL

Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1

This research study aims to find out if a new once-a-week tablet of islatravir/lenacapavir (ISL/LEN) is a safe and effective treatment option for people with HIV-1. Currently, HIV treatment usually involves taking daily tablets. This study will involve people who are already on effective daily HIV medication and whose virus levels are very low (undetectable). Some participants will switch to the new weekly tablet, while others will continue their current treatment. Researchers will be comparing these two groups to understand if the weekly tablet works as well as, or better than, their current treatment, and what side effects, if any, it might have.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Gilead Sciences

Enrolment target

600

Start

08 Oct 2024

Estimated completion

01 Aug 2030

HIV-1-Infection

What is this study about?

This study is looking into new ways to manage HIV-1. At the moment, people living with HIV-1 usually take a combination of medicines every day to keep the virus under control. These daily medicines are very effective, but researchers are always trying to find treatments that might be more convenient or have fewer side effects.

This particular study is focusing on a new tablet that combines two medicines, islatravir and lenacapavir (ISL/LEN), that could be taken just once a week. The main goal is to see if switching to this weekly tablet is just as good, or even better, than continuing the current daily treatment for people whose HIV is already well-controlled. They want to make sure the weekly tablet keeps the virus at very low levels and is safe.

The study will involve people who have HIV-1, are already on stable daily medication, and whose virus levels are so low they are considered "undetectable." This means their current treatment is working well. By comparing the new weekly tablet with the standard daily treatment, researchers hope to gather important information that could potentially lead to new, easier-to-take options for people living with HIV-1 in the future.

Key takeaways

New study compares a once-weekly HIV pill with current daily treatments.
Aims to find a more convenient way to manage HIV-1.
For people whose HIV is already well-controlled on daily medication.
Participation involves regular clinic visits and health checks.
You might receive the new weekly pill or continue your current daily treatment.

Who may be eligible?

To be considered for this study, you would need to be living with HIV-1 and your virus levels must have been very low (undetectable) for at least six months. This means your current daily HIV medication is working effectively. You also need to be currently taking a standard, recommended HIV treatment that involves two or three different medicines.

There are also some reasons why you might not be able to join. For example, if your previous HIV treatment didn't work to control the virus, or if you've already taken either of the new medicines (islatravir or lenacapavir) before. You also couldn't take part if you have certain active infections like serious tuberculosis or active hepatitis B or C. All participants must be aged 18 or over.

Women who could become pregnant and are sexually active would need to agree to use specific birth control methods throughout the study.

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?
Has your HIV been undetectable for at least 6 months?
Are you currently taking a stable, daily HIV medication?
Do you have certain active infections like TB or hepatitis B/C?
Have you ever had problems with HIV treatment not working in the past?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first go through a screening process to check if you meet all the requirements. If you do, you would be randomly assigned to one of two groups: either you would switch to the new once-weekly tablet combination (ISL/LEN), or you would continue taking your current daily HIV medication. Neither you nor the study team would be able to choose which group you are in.

You would have regular clinic visits over a long period, potentially up to two years or more. These visits would involve health checks, blood tests, and discussions about how you are feeling and any side effects you might be experiencing. The study aims to follow participants for over two years to see the long-term effects of the treatments. You would be expected to continue your assigned treatment and attend all scheduled appointments.

Potential risks and benefits

Potential benefits of taking part could include gaining early access to a new, potentially more convenient once-weekly HIV treatment. You would also receive close medical attention and monitoring throughout the study. However, like all medicines, the new weekly tablet could have side effects, some of which may not be fully known yet. There's also a chance the new treatment might not work as well for you as your current medication, or it might not be suitable for everyone. While the study aims to be as safe as possible, there are always potential risks associated with taking new medicines. Remember, participation is always voluntary, and you are free to withdraw from the study at any time without giving a reason, and this would not affect your standard medical care.

Locations (100)

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

University of Alabama at Birmingham(UAB) 1917 Research Clinic
Verified postcode
Birmingham, United States
Pueblo Family Physicians
Verified postcode
Phoenix, United States
Vv-Tmf-5366229
Verified postcode
Los Angeles, United States
Ruane Clinical Research Group
Verified postcode
Los Angeles, United States
BIOS Clinical Research
Verified postcode
Palm Springs, United States
Vivent Health
Verified postcode
Denver, United States
University of Colorado Clinical and Translational Research Center
Verified postcode
Denver, 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
Aids Healthcare Foundation - Northpoint
Verified postcode
Fort Lauderdale, United States
Midway Immunology and Research Center
Verified postcode
Ft. Pierce, United States
CAN Community Health
Verified postcode
Miami Gardens, United States

Common questions

What is HIV-1 RNA and why is it important for this study?

HIV-1 RNA is a measure of how much virus is in your blood. If it's very low (undetectable, less than 50 copies/mL), it means your current HIV treatment is working well to control the virus.

What does 'standard of care' mean in this study?

'Standard of care' refers to the usual and recommended daily HIV medications that doctors prescribe to manage HIV-1 effectively.

Will I know if I'm getting the new weekly tablet or staying on my current medicine?

No, you won't know which treatment group you are in. It's decided randomly, and this is standard practice in research to get unbiased results.

What happens if I get pregnant during the study?

Women who can become pregnant must agree to use specific birth control methods during the study to prevent pregnancy. If a pregnancy occurs, you should inform the study team immediately.

What happens if I decide I don't want to continue in the study?

You are free to leave the study at any time, for any reason, without affecting your regular medical care.