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Study on the Effects of GSK4004280 and GSK4011499 in Adults with HIV Infections

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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 effects of two new medications, GSK4004280 and GSK4011499, in adults who are newly diagnosed with HIV-1 infection and have not yet received treatment. The purpose of the study is to evaluate how these medications, taken as tablets, can help reduce the amount of the virus in the body over a period of 10 days. Participants will be randomly assigned to receive either one of the medications or a placebo, which looks like the medication but does not contain the active substance.

During the study, participants will take the medication or placebo orally, meaning by mouth, for up to 10 days. The study will monitor the safety and tolerability of the medications, which means checking for any side effects and how well participants can handle the treatment. The study will also look at how the body processes the medications, known as pharmacokinetics, to understand how the drugs are absorbed, distributed, and eliminated from the body.

Participants will have regular check-ups to measure the change in the level of HIV-1 in their blood from the start of the study to the end. The study will also track any adverse events, which are any unwanted effects that occur during the trial. After the 10-day treatment period, participants will begin a standard combination antiretroviral therapy, which is a common treatment for HIV-1 infection, to continue managing their condition.

The research process

The trial runs in 4 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, the participant will be randomly assigned to receive either the study medication or a placebo. The study is double-blind, meaning neither the participant nor the researchers will know which treatment is being administered.

  2. Step 2

    Medication administration

    The participant will take the assigned tablets orally. The tablets are oval, biconvex, plain, and white to off-white in color.

    The study involves two potential medications: VH4004280 and VH4011499. These are capsid inhibitors, which are designed to interfere with the virus's ability to replicate.

    The medication will be administered as monotherapy, meaning only one type of medication is given at a time, over a period of 10 days.

  3. Step 3

    Monitoring and assessments

    Throughout the 10-day period, the participant's health and response to the medication will be closely monitored.

    Primary assessments will focus on the change in the amount of HIV-1 ribonucleic acid (RNA) in the blood from the start of the study (Day 1) to Day 11.

    Secondary assessments will include monitoring for any adverse events, changes in liver function, and measuring the concentration of the medication in the blood.

  4. Step 4

    Completion of study medication

    On Study Day 11, the participant will complete the course of the study medication.

    Participants must be willing and able to start a locally accessible and commercially available combination antiretroviral therapy after completing the study medication.

Who can join the trial?

9 criteria

  • Are between 18 to 65 years old.
  • Are generally healthy, except for having HIV-1 infection.
  • Have a certain level of CD4+ T-cells, which are a type of white blood cell important for the immune system, with counts of 200 or more.
  • Have a confirmed HIV-1 infection and a certain amount of the virus in the blood, specifically 3000 or more copies per milliliter.
  • Have not received treatment for HIV before. Previous use of oral PreP (a medication to prevent HIV) is allowed, but not if it was given by injection.
  • Have a Body Mass Index (BMI), which is a measure of body fat based on height and weight, between 18.5 and 31.0.
  • Participants who were male at birth must use male condoms, and those who were female at birth and can have children must use acceptable birth control methods.
  • Are able to understand and sign a form agreeing to participate in the study.
  • Are willing and able to begin a combination of HIV medications that are available locally on the 11th day of the study.

Who cannot join the trial?

5 criteria

  • Individuals who have previously received treatment for HIV cannot participate. This means if you have taken any medication for HIV before, you are not eligible.
  • Participants must not have any other serious health conditions that could interfere with the study. This means if you have another major illness, you might not be able to join.
  • Pregnant or breastfeeding women are not allowed to participate. This is to ensure the safety of both the mother and the baby.
  • Individuals who are unable to follow the study procedures or attend all required visits cannot join. This means if you have difficulty keeping appointments or following instructions, you may not be eligible.
  • Participants must not be involved in another clinical trial at the same time. This is to avoid any interference between different studies.
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Investigated drugs

  • VH4004280

    is an experimental medication being tested for its ability to inhibit the capsid of the HIV-1 virus. This medication is taken orally and is being studied to see how well it can reduce the amount of virus in the body of people who have not received any previous treatment for HIV-1.

  • VH4011499

    is another experimental medication similar to VH4004280, also designed to target the capsid of the HIV-1 virus. It is administered orally and is being evaluated for its effectiveness in lowering the viral load in individuals newly diagnosed with HIV-1 who have not yet started any treatment.

What is already known about the treatment

  • VH4004280

    This medication is administered orally and is currently being studied in clinical trials for its potential to treat HIV infections. It is not yet widely recognized in medical literature as it is still under investigation. The main therapeutic indication is for HIV-1 infections, specifically in treatment-naïve adults. VH4004280 works by inhibiting the capsid protein of the virus, which is essential for viral replication. It is classified as an antiviral agent.

  • VH4011499

    This medication is also administered orally and is part of ongoing clinical trials aimed at evaluating its effectiveness in treating HIV infections. Like VH4004280, it is not yet established in medical literature due to its investigational status. It is intended for use in HIV-1 infected individuals who have not previously received treatment. VH4011499 functions by targeting the capsid protein of the virus, disrupting its ability to replicate. It belongs to the class of antiviral drugs.

Investigated diseases

HIV Infections – HIV infection is caused by the human immunodeficiency virus, which attacks the body's immune system, specifically the CD4 cells (T cells). Over time, HIV 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 of an infected person, most commonly during unprotected sex or through sharing needles. In the early stages, many people experience flu-like symptoms, but as the infection progresses, it can lead to more severe health issues. Without treatment, HIV can advance to AIDS, the final stage of the infection, where the immune system is severely damaged. The progression of the disease varies among individuals, and some may remain asymptomatic for years.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-505350-18-00Protocol code218307Estimated enrolment43 patientsSponsorViiv Healthcare UK Limited

sourced from the EU Clinical Trials Register and site verification

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