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Study Comparing Bictegravir/Lenacapavir to Current Therapy in People with HIV-1 Who Are Successfully Treated

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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 body's immune system. The study will compare two different treatments for people who have successfully managed their HIV-1 with their current medication. The first treatment being studied is a combination of two drugs, Bictegravir and Lenacapavir, taken as a single tablet. The second treatment is the current therapy, known as Biktarvy, which combines three drugs: Bictegravir, Emtricitabine, and Tenofovir Alafenamide, also taken as a single tablet.

The purpose of the study is to evaluate the effectiveness and safety of switching to the new combination of Bictegravir and Lenacapavir compared to continuing with the current therapy, Biktarvy. Participants in the study will be randomly assigned to either continue with their current therapy or switch to the new combination. The study will last for a period of up to 96 weeks, during which participants will take their assigned medication daily. Throughout the study, participants will have regular check-ups to monitor their health and the effectiveness of the treatment.

Participants will be closely monitored to ensure that their HIV-1 remains under control, with regular blood tests to measure the amount of the virus in their blood. The study will also track any side effects or adverse reactions to the medications. The goal is to determine if the new combination of Bictegravir and Lenacapavir is as effective and safe as the current therapy, Biktarvy, for maintaining control of HIV-1 in people who are already successfully treated.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying that the participant is at least 18 years old and has been receiving the current therapy, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), for at least 6 months.

    The participant's HIV-1 RNA levels must be below 50 copies/mL, both at screening and in previous measurements within the last 6 to 12 months. Additionally, there should be no resistance to the medications being tested.

  2. Step 2

    Randomization and treatment assignment

    Participants are randomly assigned to one of two treatment groups. One group continues with the current therapy, Biktarvy, while the other group switches to a new combination of medications, bictegravir/lenacapavir (BIC/LEN).

    The BIC/LEN group receives a fixed-dose combination tablet containing 75 mg of bictegravir and 50 mg of lenacapavir, taken orally.

  3. Step 3

    Treatment phase

    Participants in the BIC/LEN group take the new medication daily. The treatment phase is designed to last for 96 weeks, with evaluations at specific intervals.

    The primary goal is to maintain HIV-1 RNA levels below 50 copies/mL, with assessments at Week 48 and Week 96.

  4. Step 4

    Monitoring and evaluations

    Throughout the study, regular monitoring is conducted to assess the effectiveness and safety of the treatment. This includes measuring HIV-1 RNA levels and CD4 cell counts.

    Participants are also monitored for any adverse effects that may arise from the treatment.

  5. Step 5

    Final assessment

    At the end of the study period, a final assessment is conducted to evaluate the overall outcomes of the treatment.

    The study aims to determine the proportion of participants who maintain HIV-1 RNA levels below 50 copies/mL and to assess any changes in CD4 cell counts.

Who can join the trial?

9 criteria

  • Must be **18 years or older** at the time of screening.
  • Currently taking a specific HIV medication called **B/F/TAF** for at least **6 months** before screening.
  • If there are any **HIV-1 RNA** tests done in the last 6 months before screening, all results must show less than **50 copies/mL**. This means the virus is well controlled.
  • Must have at least one **HIV-1 RNA** test result between 6 and 12 months before screening, and all results during this time must also be less than **50 copies/mL**.
  • At the time of screening, the **HIV-1 RNA** level must be less than **50 copies/mL**.
  • No known or suspected resistance to a medication called **BIC**. This means the virus should not have certain changes (mutations) that make it resistant to BIC.
  • No known or suspected resistance to a medication called **tenofovir alafenamide (TAF)**. This means the virus should not have certain changes (mutations) that make it resistant to TAF.
  • Must have a kidney function test result, called **estimated glomerular filtration rate**, greater than **30 mL/min**. This is a measure of how well the kidneys are working.
  • Participants who were assigned female at birth and can have children must agree to use specific methods of **contraception** if they have heterosexual intercourse.

Who cannot join the trial?

7 criteria

  • Individuals who are not virologically suppressed. This means the virus is not under control in their body.
  • Individuals who are not currently taking the specific medication combination of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF).
  • Individuals who have any other medical conditions that might interfere with the study.
  • Individuals who are pregnant or breastfeeding.
  • Individuals who are unable to follow the study procedures or attend study visits.
  • Individuals who have a history of allergic reactions to any of the study medications.
  • Individuals who are participating in another clinical trial at the same time.
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Investigated drugs

  • Bictegravir/Lenacapavir

    This is a combination of two medications used in the treatment of HIV-1. Bictegravir is an antiretroviral medication that helps to prevent the virus from multiplying in the body, while Lenacapavir is another type of antiretroviral that works in a different way to stop the virus. Together, they are being studied to see if they can effectively maintain viral suppression in people who are already virologically suppressed.

  • Biktarvy® (Bictegravir/Emtricitabine/Tenofovir Alafenamide)

    This is a combination of three medications used to treat HIV-1. Bictegravir is an antiretroviral that helps stop the virus from multiplying. Emtricitabine and Tenofovir Alafenamide are also antiretrovirals that work together to further prevent the virus from spreading in the body. This combination is currently used to maintain viral suppression in people with HIV-1.

What is already known about the treatment

  • Bictegravir/Lenacapavir

    This medication is administered orally in the form of fixed-dose combination tablets. It is currently being studied in clinical trials to assess its safety and effectiveness for treating HIV-1 infection in individuals who are already virologically suppressed. The main therapeutic indication is for the management of HIV-1 infection. At the molecular level, bictegravir works by inhibiting the integrase enzyme, preventing the integration of viral DNA into the host cell genome, while lenacapavir targets the HIV capsid, disrupting viral replication. This combination falls under the pharmacological classification of antiretroviral agents.

  • Bictegravir/Emtricitabine/Tenofovir Alafenamide

    This medication is also administered orally as fixed-dose combination tablets. It is an established treatment for HIV-1 infection, particularly in individuals who are virologically suppressed. The main therapeutic indication is for the management of HIV-1 infection. Bictegravir inhibits the integrase enzyme, emtricitabine is a nucleoside reverse transcriptase inhibitor, and tenofovir alafenamide is a prodrug of tenofovir, which also inhibits reverse transcriptase. Together, they prevent the replication of the virus. This combination is classified as an antiretroviral therapy.

Investigated diseases

HIV-1 Infection – HIV-1 infection is a chronic viral condition caused by the human immunodeficiency virus type 1. This virus attacks the immune system, specifically targeting CD4 cells, which are crucial for immune defense. Over time, the virus can significantly reduce the number of these cells, weakening the body's ability to fight infections and diseases. The progression of HIV-1 infection can vary, but without intervention, it can lead to acquired immunodeficiency syndrome (AIDS). The virus is primarily transmitted through contact with infected bodily fluids, such as blood, semen, and vaginal fluids. Managing the infection involves maintaining a low viral load and preserving immune function.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510022-33-00Protocol codeGS-US-621-6290Estimated enrolment546 patientsSponsorGilead Sciences Inc.

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