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Study Comparing Bictegravir and Lenacapavir to Current Treatment in Patients with HIV-1 on Complex Regimens

Verified siteRegistered drugNo placebo
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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 Human Immunodeficiency Virus (HIV-1) infection. The study will compare a new treatment option using a combination of two medications, Bictegravir and Lenacapavir, against the current therapy that participants are already taking. The new treatment is provided in the form of film-coated tablets, which are taken orally. The purpose of the study is to evaluate the safety and effectiveness of switching to this new combination treatment in people who have successfully managed their HIV-1 with a complex regimen.

Participants in the study will be randomly assigned to either continue their current treatment or switch to the new combination of Bictegravir and Lenacapavir. The study will be conducted in two phases. In the first phase, the effectiveness of the new treatment will be assessed over a period of 24 weeks. In the second phase, the assessment will continue for up to 48 weeks. Throughout the study, participants will have regular check-ups to monitor their health and the levels of the virus in their blood. Some participants may receive a placebo, which is a tablet that looks like the medication but does not contain the active ingredients.

The study aims to determine if the new combination treatment can maintain the suppression of the virus in the blood as effectively as the current complex regimens. This trial is important for understanding if a simpler treatment option can be just as effective for people living with HIV-1. Participants will be closely monitored to ensure their safety and to gather information on any side effects that may occur during the study period.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be assigned to one of two groups. One group will continue with their current treatment, while the other group will switch to a new treatment regimen.

  2. Step 2

    Treatment regimen

    If you are in the group switching treatments, you will take a combination of bictegravir and lenacapavir. These are taken as film-coated tablets.

    The dosage for bictegravir is 75 mg, and for lenacapavir, it is 50 mg. These medications are taken orally.

  3. Step 3

    Treatment duration

    The study is divided into two phases. In Phase 2, the treatment will last for 24 weeks. In Phase 3, the treatment will continue for 48 weeks.

  4. Step 4

    Monitoring and assessments

    Throughout the study, your health will be monitored regularly. This includes checking the levels of HIV-1 RNA in your blood to ensure they remain below 50 copies/mL.

    Your CD4 cell count, which is an important measure of immune system health, will also be monitored.

  5. Step 5

    Safety and side effects

    The study will track any side effects you may experience from the treatment. This is to ensure the safety and effectiveness of the new regimen.

  6. Step 6

    Completion of the study

    At the end of the study period, your overall health and the effectiveness of the treatment will be evaluated. This will help determine the success of the new treatment regimen.

Who can join the trial?

9 criteria

  • You must have a documented level of HIV-1 RNA (a measure of the virus in your blood) that is less than 50 copies/mL for at least 6 months before the screening visit.
  • If you have had HIV-1 RNA tests in the 6 months before screening, all results must be less than 50 copies/mL.
  • You must currently be on a complex antiretroviral (ARV) regimen (a combination of drugs used to treat HIV) for at least 6 months before the screening visit. This means:
    • Your regimen includes a boosted protease inhibitor or a nonnucleos(t)ide reverse transcriptase inhibitor (NRTI) plus at least one other third agent from a different class.
    • Your regimen involves taking two or more pills a day or requires dosing more than once daily.
    • Your regimen includes injectable medications along with oral medications, but not a complete long-acting injectable regimen.
    • You must not have any documented or suspected resistance to bictegravir (BIC), a medication used in the study.
    • Your estimated glomerular filtration rate (eGFR) (a measure of kidney function) must be at least 15 mL/min, and you should not be on dialysis or other renal replacement therapy.
    • Both males and females can participate.
    • Participants from vulnerable populations are included.

Who cannot join the trial?

10 criteria

  • Participants cannot have any other serious health conditions that might interfere with the study.
  • Participants should not have a history of allergic reactions to the study medications.
  • Participants must not be pregnant or breastfeeding.
  • Participants should not have a history of substance abuse that could affect their ability to follow the study procedures.
  • Participants must not have participated in another clinical trial within the last 30 days.
  • Participants should not have any mental health conditions that could interfere with their ability to understand and follow the study instructions.
  • Participants must not have any active infections other than **HIV-1**.
  • Participants should not have any liver problems that could affect the study results.
  • Participants must not have any kidney problems that could affect the study results.
  • Participants should not have any heart conditions that could interfere with the study.
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Investigated drugs

  • Bictegravir

    is a medication used to treat HIV-1, which is the most common type of HIV. It works by blocking a key enzyme that the virus needs to multiply in the body. By doing this, bictegravir helps to lower the amount of virus in the blood, which can improve the immune system and reduce the risk of developing HIV-related illnesses.

  • Lenacapavir

    is another medication used in the treatment of HIV-1. It works differently from other HIV medications by targeting a specific part of the virus's life cycle. Lenacapavir helps to prevent the virus from multiplying, which can help keep the virus under control and maintain a healthy immune system. This medication is often used in combination with other HIV treatments to enhance its effectiveness.

What is already known about the treatment

Bictegravir/Lenacapavir – This medication is administered orally in the form of a fixed-dose combination tablet. It is currently being studied in clinical trials for its effectiveness in treating people with HIV-1 who are already virologically suppressed on complex treatment regimens. The main therapeutic indication is for the management of HIV-1 infection. At the molecular level, bictegravir works by inhibiting the integrase enzyme, which is essential for the virus to replicate, while lenacapavir targets the capsid protein, disrupting the virus's ability to assemble and mature. This combination falls under the pharmacological classification of antiretroviral agents, specifically integrase strand transfer inhibitors and capsid inhibitors.

Investigated diseases

Human Immunodeficiency Virus (HIV-1) infection – HIV-1 infection is a viral disease caused by the human immunodeficiency virus type 1, which attacks the immune system, specifically targeting CD4 cells. As the virus replicates, it gradually weakens the immune system, making the body more susceptible to infections and certain cancers. The progression of the disease can vary, but without intervention, it typically advances from an acute phase to a chronic phase, eventually leading to acquired immunodeficiency syndrome (AIDS). During the acute phase, individuals may experience flu-like symptoms, while the chronic phase can be asymptomatic or involve mild symptoms. Over time, the depletion of CD4 cells can lead to severe immune dysfunction. The disease is primarily transmitted through contact with infected bodily fluids, such as blood, semen, vaginal fluids, and breast milk.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2022-500929-33-01Protocol codeGS-US-621-6289Estimated enrolment688 patientsSponsorGilead Sciences Inc.

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