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Study on Budigalimab and ABBV-382 for People with HIV on Stable Antiretroviral Therapy

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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 treatments for people living with HIV who are on stable antiretroviral therapy. The study will evaluate two treatments: Budigalimab and ABBV-382. Budigalimab is a humanized, recombinant IgG1 monoclonal antibody, which is a type of protein designed to target specific parts of the immune system. ABBV-382 is also a humanized IgG1 monoclonal antibody, specifically targeting a protein called alfa4beta7 integrin. These treatments will be compared to a placebo to understand their effects better.

The purpose of the study is to assess the effectiveness, safety, and tolerability of Budigalimab and/or ABBV-382 in individuals with HIV who are undergoing a planned break from their regular antiretroviral therapy. Participants will receive either Budigalimab, ABBV-382, or a placebo. The study will monitor how well the treatments work in controlling the virus without the need to restart antiretroviral therapy. It will also look at how the body processes these treatments.

Participants will be involved in the study for several months, during which they will receive the treatments through injections or infusions. The study will track the viral load, which is the amount of HIV in the blood, to see if it stays below a certain level without restarting antiretroviral therapy. The study will also observe how long it takes for the virus to rebound, or increase, if it does. This research aims to provide more information on potential new treatments for managing 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

    Joining the study

    Upon joining the study, participants are required to be living with HIV, aged between 18 and 70 years, in good health, and on antiretroviral therapy (ART) for at least 12 months prior to screening. The current ART regimen must have been stable for at least 8 weeks before screening.

    Participants must have a negative HIV-2 antibody test at screening, plasma HIV-1 RNA levels below the lower limit of quantification at screening and for at least 12 months prior, and a CD4+ T cell count of 500 cells/μL or higher at screening.

  2. Step 2

    Treatment administration

    Participants will receive either budigalimab, ABBV-382, or a placebo. Budigalimab is a humanized monoclonal antibody administered either intravenously (IV) or subcutaneously (SC). ABBV-382 is also administered as a solution for injection or infusion.

    The specific dosage, frequency, and duration of administration will be determined by the study protocol and communicated to participants during the trial.

  3. Step 3

    Analytical treatment interruption (ATI)

    Participants will undergo an analytical treatment interruption, during which their regular ART will be paused. The objective is to evaluate the efficacy, safety, and tolerability of the study medications in maintaining viral control without ART.

  4. Step 4

    Monitoring and evaluation

    Participants will be monitored for viral control, defined as maintaining a viral load of less than 1000 copies/mL at Week 24 without restarting ART.

    Secondary evaluations include measuring the peak viral load at rebound before restarting ART and the time to first rebound to 1000 copies/mL or more during the ART interruption.

  5. Step 5

    Completion of the study

    The study is estimated to conclude by December 31, 2026. Participants will be informed of their results and any necessary follow-up actions at the end of the study.

Who can join the trial?

9 criteria

  • Participants must be people living with HIV (Human Immunodeficiency Virus).
  • Participants should be between 18 and 70 years old.
  • Participants must be in generally good health.
  • Participants need to have been on ART (Antiretroviral Therapy) for at least 12 months before the screening.
  • Participants should be on their current ART regimen for at least 8 weeks before the screening.
  • Participants must have a negative test for HIV-2 antibodies at screening. This means they should not have HIV-2, a different type of HIV.
  • Participants need to have their HIV-1 RNA (a measure of the virus in the blood) below the level of detection at screening and for at least 12 months before screening.
  • Participants should have a CD4+ T cell count of 500 cells per microliter or more at screening. CD4+ T cells are a type of white blood cell important for the immune system.
  • Participants should not have had a CD4+ T cell count below 500 cells per microliter in the last 12 months before screening.

Who cannot join the trial?

6 criteria

  • Individuals who are not living with HIV infection cannot participate. HIV infection is a condition caused by the human immunodeficiency virus, which affects the immune system.
  • Participants must be on stable ART (antiretroviral therapy). ART is a treatment that helps control HIV infection.
  • Participants must be undergoing ATI (analytical treatment interruption). ATI is a planned break from HIV treatment under medical supervision.
  • Individuals outside the specified age ranges cannot participate. The study is open to certain age groups only.
  • Both male and female participants are eligible, but certain criteria may apply to each gender.
  • Individuals considered part of a vulnerable population may have specific criteria for participation.
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Investigated drugs

  • Budigalimab

    is a medication being studied for its potential to help people living with HIV. It is being tested to see how well it works, how safe it is, and how well people can tolerate it when they temporarily stop their regular HIV treatment.

  • ABBV-382

    is another medication included in the study. Like Budigalimab, it is being evaluated for its effectiveness, safety, and tolerability in people with HIV who are on stable antiretroviral therapy and are undergoing a planned interruption of their treatment.

What is already known about the treatment

  • Budigalimab

    Budigalimab is administered via injection and is currently being studied in clinical trials for its potential use in treating HIV infection. It is not yet widely available in medical practice, as it is still under investigation. The main therapeutic indication for Budigalimab is to help manage HIV infection in individuals who are already on stable antiretroviral therapy. At the molecular level, Budigalimab works by targeting specific proteins involved in the immune response, potentially enhancing the body's ability to control HIV. It is classified as a monoclonal antibody in pharmacology.

  • ABBV-382

    ABBV-382 is also administered through injection and is being evaluated in clinical trials for its effectiveness in treating HIV infection. Like Budigalimab, it is not yet approved for general medical use and is under investigation. The primary therapeutic indication for ABBV-382 is to assist in managing HIV infection in patients on stable antiretroviral therapy. Its mechanism of action involves modulating immune system components to improve the body's response to HIV. ABBV-382 is classified as an investigational drug in the context of its current clinical trials.

Investigated diseases

HIV Infection – 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 progression of HIV infection can be divided into three stages: acute HIV infection, clinical latency, and acquired immunodeficiency syndrome (AIDS). During the acute phase, individuals may experience flu-like symptoms as the virus rapidly multiplies. In the clinical latency stage, the virus is still active but reproduces at very low levels, and individuals may not have any symptoms. If untreated, HIV can progress to AIDS, where the immune system is severely damaged, leading to increased vulnerability to opportunistic infections.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-505900-53-00Protocol codeM19-965Estimated enrolment136 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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