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Study of IMC-M113V for Patients with Chronic HIV Infection Who Are Virologically Suppressed

Verified siteInvestigationalNo 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 chronic HIV infection, a condition where the human immunodeficiency virus (HIV) remains in the body for a long time, even when symptoms are not present. The trial is testing a new treatment called IMC-M113V, which is a special type of protein designed to help the immune system fight the virus. This protein is given to participants as a solution through an infusion, which means it is delivered directly into the bloodstream.

The purpose of the study is to evaluate the safety and effects of IMC-M113V in people who have chronic HIV infection and are already on antiretroviral therapy (ART), a common treatment for HIV. The study is divided into two parts. In the first part, participants will receive a single dose of the treatment to see how their bodies react. In the second part, participants will receive multiple doses over a period of time, up to at least 12 weeks, to further assess the treatment's safety and how well it is tolerated.

Throughout the study, researchers will monitor participants for any side effects and changes in their health. They will also check how the body processes the treatment and whether it affects the levels of HIV in the blood. The study aims to find a safe and effective dosing schedule for IMC-M113V that could be used in future research. Participants will continue their regular HIV treatment during the study, and their health will be closely watched by the research team.

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

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, weight, and health status related to chronic HIV infection.

    Participants must be between 18-65 years old, weigh at least 50 kg, and have been on continuous antiretroviral therapy (ART) for 12 months to 7 years with undetectable HIV levels.

  2. Step 2

    Single ascending dose (SAD) phase

    In this phase, a single dose of the study drug IMC-M113V is administered as a solution for infusion.

    The focus is on evaluating the safety and tolerability of this single dose while continuing ART.

  3. Step 3

    Multiple ascending dose (MAD) phase

    Participants receive multiple doses of IMC-M113V over a period of up to 12 weeks.

    The aim is to assess the safety and tolerability of repeated doses while on ART.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, participants are monitored for any adverse effects, changes in vital signs, and laboratory parameters.

    Regular assessments include checking for the formation of antibodies against IMC-M113V and changes in blood cell counts.

  5. Step 5

    Post-treatment evaluation

    After the last infusion, participants are observed for 28 days to monitor any treatment-emergent adverse events.

    The study also evaluates the duration of viral suppression after ART interruption and identifies tolerable dosing regimens for future studies.

Who can join the trial?

10 criteria

  • Age between 18 and 65 years.
  • Must be **HLA-A*02:01-positive**. This is a specific genetic marker that can be checked with a blood test.
  • Weigh at least 50 kg (about 110 pounds).
  • Have evidence of **HIV-1 infection**. This means you have been diagnosed with HIV-1.
  • Have been on continuous **antiretroviral therapy (ART)** for at least 12 months but not more than 7 years. ART is the treatment for HIV.
  • Have consistently undetectable **plasma HIV RNA** levels, which means less than 50 copies/mL, for the 12 months before the study starts. This shows that the virus is well-controlled.
  • Have a current **CD4+ T cell count** greater than 500 cells/μL. CD4+ T cells are a type of white blood cell important for your immune system.
  • Have a **CD4+ T cell nadir** greater than 200 cells/μL. The nadir is the lowest point your CD4+ T cell count has ever been.
  • Agree to use **contraception** if you are of childbearing potential. This is to prevent pregnancy during the study.
  • Provide **informed consent**, which means you understand the study and agree to participate.

Who cannot join the trial?

5 criteria

  • Individuals who do not have a chronic HIV infection cannot participate. This means the study is only for those who have had HIV for a long time.
  • Participants must be currently receiving antiretroviral therapy (ART). This is a treatment for HIV that helps control the virus in the body.
  • People who are not within the specified age range for the study cannot join. The study is for certain age groups only.
  • Both males and females can participate, but those who do not identify as either may not be eligible.
  • Individuals who are considered part of a vulnerable population may not be eligible. This term refers to groups who might need special protection or care.
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Investigated drugs

IMC-M113V is a medication being studied for its safety and effectiveness in people with chronic HIV infection. It is being tested in individuals who are already on antiretroviral therapy (ART) and have their virus under control. The study is looking at how well people tolerate the medication when given as a single dose and also when given multiple times over a period of at least 12 weeks.

What is already known about the treatment

IMC-M113V – This medication is administered through injection and is currently being studied in clinical trials for its safety and effectiveness in treating chronic HIV infection. It is specifically being tested in individuals who are virologically suppressed and positive for the HLA-A*2:01 gene. The main therapeutic indication is to manage chronic HIV infection in these patients. IMC-M113V works by targeting specific immune cells to enhance the body's ability to control HIV. It is classified as an antiviral agent, and its development is focused on improving outcomes for patients already on antiretroviral therapy.

Investigated diseases

Chronic HIV Infection – This is a long-term condition caused by the human immunodeficiency virus (HIV), 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 progression of the disease can be divided into stages, starting with acute infection, followed by clinical latency, and eventually leading to acquired immunodeficiency syndrome (AIDS) if untreated. During the chronic phase, the virus is still active but reproduces at very low levels, and individuals may not have symptoms or only mild ones. Without treatment, the disease can progress to AIDS, where the immune system is severely damaged. Regular monitoring and antiretroviral therapy can help manage the condition and maintain a healthy immune system.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-513938-38-00Protocol codeIMC-M113V-103Estimated enrolment30 patientsSponsorImmunocore Limited

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