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A study testing VH4524184 with emtricitabine and tenofovir alafenamide compared to dolutegravir and lamivudine in adults with HIV-1 who have not received treatment before

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What is this trial about?

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

This study involves people living with HIV-1 infection who have not received treatment before. The study will compare different treatment approaches. Some people will receive tablets containing an investigational medicine called VH4524184 (also known as GSK4524184) together with a combination of two approved medicines, emtricitabine and tenofovir alafenamide, which are given as a single tablet called Descovy. Other people will receive a different approved combination treatment called Dovato, which contains lamivudine and dolutegravir sodium. All medicines in this study are taken by mouth. These medicines belong to a group called antiretroviral treatments, which work to control the virus in the body.

The purpose of this study is to find out how well the investigational treatment containing VH4524184 works in reducing the amount of virus in the blood compared to the approved treatment, and to check how safe these treatments are. The study will look at whether the amount of virus in the blood drops to very low levels and stays low during the treatment period. The study will also measure changes in certain blood cells that are important for the immune system and will check for any side effects that may occur during treatment.

People who join this study will be assigned to receive one of the treatment combinations and will take their assigned medicine for up to 24 months. During this time, they will have regular visits where blood samples will be collected to measure the amount of virus in the blood and to check their overall health. The study will monitor how well the treatment works and how people respond to it over time. The study is expected to start in early 2026 and continue until late 2028.

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 treatment assignment

    On the first day of the study, treatment will be assigned. The study medication will be administered orally.

    Treatment will consist of either VH4524184 combined with emtricitabine and tenofovir alafenamide (one treatment option), or dolutegravir and lamivudine (control treatment option).

    All medications are taken by mouth in tablet form.

  2. Step 2

    Daily medication intake during treatment period

    The assigned medication regimen will be taken daily throughout the treatment period.

    If assigned to VH4524184 with emtricitabine and tenofovir alafenamide, this combination will be taken as film-coated tablets by mouth.

    If assigned to the control treatment, Dovato (containing 50 mg lamivudine and 300 mg dolutegravir) will be taken as film-coated tablets by mouth.

    The alternative control option is Descovy (containing 200 mg emtricitabine and 25 mg tenofovir alafenamide) taken as film-coated tablets by mouth.

  3. Step 3

    Assessment at month 12

    At month 12, the primary assessment will be conducted to measure the amount of HIV-1 virus in the blood.

    The goal is to determine if the virus level has decreased to less than 50 copies per milliliter of blood plasma.

    Blood samples will be collected to measure CD4+ T-cell count, which indicates how well the immune system is functioning.

  4. Step 4

    Continued treatment and monitoring until month 24

    Treatment will continue with daily medication intake until month 24.

    Regular assessments will be performed to monitor the virus level in the blood, with the target of maintaining levels below 50 copies per milliliter.

    Blood tests will be conducted periodically to track changes in CD4+ T-cell count from the initial baseline measurement.

    Safety monitoring will occur throughout this period to assess how well the medication is tolerated and to identify any side effects.

  5. Step 5

    Final assessment at month 24

    At month 24, final assessments will be completed.

    Blood samples will be analyzed to confirm virus levels remain below 50 copies per milliliter.

    The final measurement of CD4+ T-cell count will be taken and compared to the baseline value to evaluate immune system improvement.

    A comprehensive safety evaluation will be conducted to review the overall tolerability of the treatment regimen throughout the study period.

Who can join the trial?

9 criteria

  • You must be at least 18 years old when you sign the consent form
  • Your CD4+ T-cell count (a type of white blood cell that helps fight infections) must be 200 cells per microliter or higher at the screening visit
  • You must have confirmed HIV-1 infection (a specific type of HIV virus) and your plasma HIV-1 RNA (the amount of virus in your blood) must be 1000 copies per milliliter or higher at screening
  • You must be treatment-naïve, which means you have never taken HIV medicines after being diagnosed with HIV-1 infection. If you previously used HIV prevention medicines taken by mouth before or after possible exposure to HIV, you can still participate. However, if you previously used long-acting injectable cabotegravir, you cannot participate
  • If you are enrolling in France, you must be part of or benefit from the social security system
  • Your body weight must be at least 50.0 kilograms (110 pounds) if you were assigned male at birth, or at least 45.0 kilograms (99 pounds) if you were assigned female at birth. Your BMI (body mass index, which is a measure of body fat based on height and weight) must be between 18.5 and 35.5
  • If you were assigned male at birth, there are no birth control requirements for you
  • If you were assigned female at birth, you must not be pregnant or breastfeeding. You must either be unable to become pregnant, or you must use a highly effective birth control method (with less than 1% failure rate) before the study, during the study, and for at least 1 week after the last dose of the study medicine. You must have a negative pregnancy test at screening and on the first day of treatment
  • You must be able to sign the consent form and follow all study requirements and restrictions

Who cannot join the trial?

3 criteria

  • The source data does not provide specific exclusion criteria, which are reasons why a patient cannot participate in the study
  • Without detailed exclusion criteria information, it is not possible to list the specific conditions or situations that would prevent participation in this trial
  • Typically, exclusion criteria may include things like certain other health conditions, medications you are taking, pregnancy status, or previous treatments, but these specific details are not available in the provided information
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Investigated drugs

  • VH4524184

    is an investigational medication being studied as a treatment for HIV-1 infection. It is taken by mouth and is being tested in combination with other HIV medications to see if it can effectively reduce the amount of virus in the blood of people who have not received HIV treatment before.

  • Emtricitabine

    is an antiviral medication used to treat HIV infection. It works by blocking an enzyme that the virus needs to multiply, helping to reduce the amount of HIV in the body and improve the immune system.

  • Tenofovir Alafenamide

    is an antiviral medication used to treat HIV infection. It works by interfering with the virus's ability to reproduce, which helps control the infection and allows the immune system to work better.

  • Dolutegravir

    is an antiviral medication used to treat HIV infection. It belongs to a class of drugs called integrase inhibitors, which prevent the virus from inserting its genetic material into human cells, thereby stopping the virus from multiplying.

  • Lamivudine

    is an antiviral medication used to treat HIV infection. It helps prevent the virus from multiplying in the body, which reduces the viral load and helps protect the immune system.

What is already known about the treatment

  • VH4524184

    VH4524184 is an experimental oral medication currently being studied in clinical trials for the treatment of HIV-1 infection in people who have not previously received HIV treatment. It is taken by mouth in combination with two other antiviral drugs called emtricitabine and tenofovir alafenamide, and works by blocking specific steps in the virus's ability to multiply inside human cells. The medication belongs to a class of drugs designed to stop HIV from replicating, helping to reduce the amount of virus in the blood and improve immune system function.

  • Emtricitabine

    Emtricitabine is an approved oral antiviral medication used as part of combination therapy to treat HIV-1 infection. It is taken by mouth, usually once daily, and works by interfering with an enzyme called reverse transcriptase that the virus needs to copy its genetic material and multiply inside cells. This medication belongs to a class of drugs known as nucleoside reverse transcriptase inhibitors, which help reduce the amount of HIV in the body and allow the immune system to work better.

  • Tenofovir Alafenamide

    Tenofovir alafenamide is an approved oral antiviral medication used in combination with other drugs to treat HIV-1 infection. It is taken by mouth and works by blocking reverse transcriptase, an enzyme that HIV uses to reproduce and spread to new cells in the body. This medication is classified as a nucleotide reverse transcriptase inhibitor and helps lower the viral load while improving immune function, and it is designed to be effective at lower doses with potentially fewer side effects on kidneys and bones compared to older forms of tenofovir.

Investigated diseases

HIV Infections – HIV Infections are caused by the Human Immunodeficiency Virus, which attacks the body's immune system. The virus specifically targets cells that help the body fight off infections and diseases. When HIV enters the body, it begins to multiply and gradually weakens the immune system over time. As the infection progresses, the body becomes less able to defend itself against various illnesses. Without proper management, the number of immune cells decreases significantly. The virus spreads through contact with certain body fluids from an infected person.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521918-26-00Protocol code222638Estimated enrolment440 patientsSponsorViiv Healthcare UK Limited

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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