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Study on Lenacapavir for HIV Prevention in Individuals at Risk of HIV Infection

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 prevention of Human Immunodeficiency Virus (HIV-1) infection, a virus that attacks the body's immune system. The study will evaluate a treatment called Lenacapavir, which is being tested for its effectiveness in preventing HIV. Lenacapavir is available in two forms: a 300 mg film-coated tablet and a 464 mg solution for injection. The tablet is taken orally, while the injection is administered under the skin. Lenacapavir is also known by its code names, GS-6207 and GS-CA1. Another medication involved in the study is a combination of Emtricitabine and Tenofovir Disoproxil Fumarate, which is taken orally.

The purpose of the study is to compare the effectiveness and safety of Lenacapavir with the combination of Emtricitabine and Tenofovir Disoproxil Fumarate in people who could benefit from HIV prevention. Participants will receive either the Lenacapavir injection twice a year or the oral combination medication. The study will monitor how well these treatments work in preventing HIV over a period of time, as well as their safety and how acceptable they are to participants.

Throughout the study, participants will have regular visits to receive their treatment and undergo health assessments. The study aims to provide valuable information on the long-term use of Lenacapavir for HIV prevention, helping to determine if it is a safe and effective option for people at risk of acquiring HIV.

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 visit and screening

    Upon joining the study, you will have an initial visit where you will undergo a screening process. This includes a test to confirm that you do not have HIV. Your kidney function will also be checked to ensure it is normal.

    You will be asked to provide information about your health and lifestyle, including any medications you are taking and your sexual health history. This is to confirm your eligibility for the study.

  2. Step 2

    First medication administration

    If eligible, you will receive your first dose of Sunlenca 300 mg film-coated tablets for oral use. This medication is part of the study treatment.

    You will also receive an injection of Sunlenca 464 mg solution for subcutaneous use. This injection is given under the skin and is part of the long-acting treatment.

  3. Step 3

    Follow-up visits

    You will have follow-up visits at regular intervals. These visits are important to monitor your health and the effects of the medication.

    During these visits, you may be asked to provide blood samples and answer questions about how you are feeling and any side effects you may be experiencing.

  4. Step 4

    Second medication administration

    At week 26, you will receive another injection of Sunlenca 464 mg solution for subcutaneous use. This is to maintain the medication's effectiveness.

    You will continue to take the oral medication as directed by the study team.

  5. Step 5

    Final follow-up visit

    At week 52, you will have a final follow-up visit. This visit will include a comprehensive health check and a review of your experience during the study.

    You will be asked to provide feedback on the acceptability of the treatment and any side effects you experienced.

Who can join the trial?

13 criteria

  • Able to understand and sign a written consent form before starting the study.
  • Includes cisgender men who have sex with men, transgender women, transgender men, cisgender women, and nonbinary people.
  • Must be at least 18 years old at the time of screening.
  • Higher chance of getting HIV, shown by at least one of these:
    • Having sex without a condom with 2 or more partners in the last 6 months.
    • Diagnosed with a bacterial sexually transmitted infection (STI) in the last 12 months.
    • Involved in sex work or transactional sex in the last 12 months.
    • Used 2 or more courses of nonoccupational HIV postexposure prophylaxis (nPEP) in the last 12 months.
    • Had sex without a condom with a partner who has HIV and an unknown or high viral load (≥ 200 copies/mL) in the last 12 months.
    • Must have a negative HIV test at screening.
    • Kidney function must be at least 60 mL/min as measured by a specific formula.
    • Body weight must be at least 35 kg (about 77 pounds).
    • Willing and able to follow the study procedures.
    • If able to become pregnant and taking certain medications, must not plan to become pregnant during the study and must agree to use specific methods of contraception.

Who cannot join the trial?

1 criterion

  • People who are currently infected with Human Immunodeficiency Virus (HIV-1) cannot participate. This is a virus that affects the immune system.
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Investigated drugs

  • Lenacapavir

    is a medication being studied for its potential to help prevent HIV infection. It is given as a long-acting injection under the skin, which means it doesn't have to be taken every day like some other HIV prevention medications. This could make it easier for people to stick to their prevention plan. The study is looking at how well this medication works over time, how safe it is for people to use, and how acceptable it is for people who might benefit from it.

  • Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF)

    is a combination of two medications that are already used to help prevent HIV infection. It is usually taken as a pill once a day. This combination works by stopping the virus from multiplying in the body, which helps prevent infection. The study is comparing how well people stick to taking this medication regularly compared to the new medication, Lenacapavir, to see which one might be more effective or easier for people to use consistently.

What is already known about the treatment

Lenacapavir – Lenacapavir is administered as a long-acting subcutaneous injection, meaning it is injected under the skin and slowly releases the medication over time. It is currently being studied in clinical trials for its effectiveness and safety in preventing HIV-1 infection in people who could benefit from pre-exposure prophylaxis (PrEP). The medication works by interfering with the virus's ability to replicate, thereby reducing the risk of infection. Lenacapavir is classified as an antiretroviral drug, specifically targeting the HIV-1 virus to prevent its spread in the body.

Investigated diseases

Human Immunodeficiency Virus (HIV-1) infection – HIV-1 infection is caused by the human immunodeficiency virus type 1, which attacks the body's immune system, specifically the CD4 cells (T cells). Over time, HIV-1 can destroy so many of these cells that the body can't fight off infections and disease. The virus is transmitted through contact with certain body fluids from a person who has HIV-1. As the infection progresses, individuals may experience flu-like symptoms, but many remain asymptomatic for years. Without intervention, HIV-1 can lead to acquired immunodeficiency syndrome (AIDS), where the immune system is severely compromised. The progression of the disease varies among individuals, influenced by factors such as viral load and the individual's immune response.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2023-507891-31-00Protocol codeGS-US-528-6727Estimated enrolment262 patientsSponsorGilead Sciences Inc.

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