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Study to Compare Weekly Islatravir/Lenacapavir with Bictegravir/Emtricitabine/Tenofovir in People with HIV-1 Who Are Virologically Suppressed

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of HIV-1 infection, a virus that attacks the immune system. The study will compare two different treatment regimens for people who have their virus under control. One group will switch to a new treatment involving a combination of two medications, Islatravir and Lenacapavir, taken as a weekly tablet. The other group will continue their current daily treatment with a combination of three medications: Bictegravir, Emtricitabine, and Tenofovir Alafenamide, known as Biktarvy.

The purpose of the study is to evaluate the effectiveness of switching to the weekly Islatravir/Lenacapavir regimen compared to continuing the daily Biktarvy regimen. Participants will be randomly assigned to one of the two groups and will not know which treatment they are receiving. The study will last for 48 weeks, during which participants will have regular check-ups to monitor their health and the level of the virus in their blood. The main goal is to see if the new weekly treatment is as effective as the daily treatment in keeping the virus suppressed.

Throughout the study, participants will be closely monitored for any changes in their health, including their immune cell counts, which are important for fighting infections. The study will also track any side effects that may occur from the treatments. This research aims to provide more options for people living with HIV-1, potentially offering a more convenient weekly treatment regimen.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Beginning of the trial

    Upon joining the study, you will continue taking your current medication, which is a combination of bictegravir, emtricitabine, and tenofovir alafenamide. This medication is taken orally as a film-coated tablet.

    You will continue this regimen until the first day of the trial, ensuring that your HIV-1 RNA levels remain below 50 copies/mL.

  2. Step 2

    Switch to new medication

    On the first day of the trial, you will switch to a new medication regimen consisting of islatravir and lenacapavir. This medication is taken orally as a tablet.

    The new regimen is administered once a week. It is important to adhere to this schedule to maintain the effectiveness of the treatment.

  3. Step 3

    Monitoring and follow-up

    Throughout the trial, your health and HIV-1 RNA levels will be closely monitored. Regular check-ups will be scheduled to ensure the treatment is working effectively.

    At Week 48, the primary goal is to evaluate the effectiveness of the new medication regimen in keeping your HIV-1 RNA levels below 50 copies/mL.

  4. Step 4

    Extended monitoring

    The trial will continue to monitor your health and HIV-1 RNA levels up to Week 96. This extended period helps to assess the long-term effectiveness and safety of the new medication regimen.

    Your CD4 T-cell count, which is an important measure of immune system health, will also be evaluated at Weeks 48 and 96.

  5. Step 5

    Completion of the trial

    Upon completion of the trial, the data collected will be analyzed to determine the overall success of the new medication regimen.

    Your participation will contribute to understanding the potential benefits and risks of switching to the weekly islatravir and lenacapavir regimen for people with HIV-1.

Who can join the trial?

5 criteria

  • Participants must be 18 years of age or older and able to understand and give written consent to join the study.
  • Participants must have HIV-1 RNA levels (a measure of the virus in the blood) of less than 50 copies/mL for at least 6 months before joining the study. This means the virus is well controlled.
  • Participants must have HIV-1 RNA levels of less than 50 copies/mL at the time of joining the study.
  • Participants must have been taking a specific HIV treatment called B/F/TAF for at least 6 months before joining the study and be willing to continue it until the study starts. B/F/TAF is a combination of medicines used to treat HIV.
  • Participants who were assigned female at birth and can have children must agree to use specific methods of birth control if they have heterosexual intercourse.

Who cannot join the trial?

9 criteria

  • Patients who are not virologically suppressed cannot participate. This means that the virus is not controlled or reduced to very low levels in their body.
  • Patients who are not within the specified age range cannot participate. The study is for certain age groups only.
  • Patients who are not willing or able to follow the study procedures cannot participate.
  • Patients with certain medical conditions other than HIV-1 infection may be excluded.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients with a history of allergic reactions to the study medications cannot participate.
  • Patients with certain liver or kidney problems may be excluded.
  • Patients who are using medications that might interfere with the study drugs cannot participate.
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Investigated drugs

  • Islatravir

    is a medication being studied for its potential to help control HIV. It is taken orally once a week and works by interfering with the virus's ability to multiply in the body. This helps to keep the virus at low levels, which is important for maintaining health in people living with HIV.

  • Lenacapavir

    is another medication in the study that is also taken orally once a week. It is designed to block a specific part of the HIV virus, preventing it from replicating. By doing so, it helps to keep the virus under control in the body, which is crucial for people who are managing HIV.

  • Bictegravir

    is a medication that is part of a combination treatment for HIV. It works by stopping the virus from multiplying, which helps to reduce the amount of virus in the body. This medication is typically taken daily as part of a regimen to maintain viral suppression.

  • Emtricitabine

    is used in combination with other medications to treat HIV. It helps to lower the amount of virus in the body by interfering with the virus's ability to reproduce. This medication is an important part of a daily treatment plan for people with HIV.

  • Tenofovir

    is another medication that is used alongside others to manage HIV. It works by blocking the virus from multiplying, which helps to keep the virus at low levels in the body. This medication is taken daily and is a key component of a comprehensive HIV treatment strategy.

What is already known about the treatment

Islatravir/Lenacapavir – This medication is administered orally in the form of a weekly tablet. It is currently being studied in clinical trials as a potential treatment for people with HIV-1 who are already virologically suppressed. The main therapeutic indication is to maintain viral suppression in individuals with HIV-1. At the molecular level, Islatravir works by interfering with the virus's ability to replicate, while Lenacapavir blocks a protein that the virus needs to multiply. This combination falls under the pharmacological classification of antiretroviral agents, which are drugs used to treat infections caused by retroviruses like HIV.

Investigated diseases

HIV-1 Infection – HIV-1 Infection is a chronic viral infection caused by the human immunodeficiency virus type 1. The virus attacks the body's immune system, specifically the CD4 T-cells, which are crucial for immune response. Over time, the virus reduces the number of these cells, weakening the immune system and making the body more susceptible to other infections and diseases. The progression of the infection can vary, but without intervention, it can lead to acquired immunodeficiency syndrome (AIDS). The infection is primarily spread through contact with infected bodily fluids, such as blood, semen, and vaginal fluids. The disease progresses through several stages, starting with acute infection, followed by clinical latency, and eventually leading to AIDS if untreated.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514046-37-00Protocol codeGS-US-563-5925Estimated enrolment612 patientsSponsorGilead Sciences Inc.

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