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Durable HIV-1 control with 10-1074-LS, 3BNC117-LS and nivolumab in adults on ART: a randomized double‑blind placebo‑controlled trial

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What is this trial about?

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

The study focuses on people living with HIV-1 disease and evaluates a treatment that combines two long‑acting broadly neutralizing antibodies, 10-1074-LS and 3BNC117-LS, with a low dose of an anti‑PD‑1 medication, nivolumab. Participants will be compared with a group receiving a standard saline solution used as a placebo.

The purpose of the trial is to determine whether this combination can achieve durable immunological control of the virus when antiretroviral therapy is stopped. After receiving the study infusions, participants will pause their regular ART under close medical supervision and will have regular blood tests to monitor viral levels and immune‑cell counts; if the virus rises above predefined thresholds or immune cells fall, treatment will be restarted.

During the entire study period, participants will be monitored for any side effects or laboratory changes, and any serious problems will be reported to the study team, with follow‑up extending for several months after the therapy interruption.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit and consent

    You attend the clinic for the first time after being assigned to the study. the study staff explains the purpose, procedures, possible risks, and your rights. you sign a consent form indicating that you understand and agree to participate.

  2. Step 2

    Baseline assessments

    A series of medical evaluations are performed before any study medication is given. this includes physical examination, blood draws to measure viral load, cd4+ t cell count, and other laboratory tests. the results establish your starting point for later comparisons.

  3. Step 3

    Randomization to treatment group

    Based on a computer-generated schedule, you are placed into one of the study arms. each arm receives a specific combination of infusions: the test arm receives the two antibodies 3bnc117-ls and 10-1074-ls together with a low dose of nivolumab; the comparator arm receives a placebo infusion of sodium chloride together with the same low dose of nivolumab.

  4. Step 4

    First infusion session

    You receive an intravenous infusion in a clinic setting. the infusion contains:

    - 3bnc117-ls at a dose of 30 mg per kilogram of body weight, administered as a solution for injection.

    - 10-1074-ls at a dose of 10 mg per kilogram of body weight, administered as a solution for injection.

    - nivolumab at a dose of 1 mg per kilogram of body weight, given by intravenous infusion.

    If you are in the comparator arm, the antibody infusions are replaced by a placebo infusion of sodium chloride 0.9% at 1 mg per kilogram, also given intravenously. the infusion is performed over a period of time determined by the study staff, and you are monitored for any immediate reactions.

  5. Step 5

    Subsequent infusion visits

    Additional infusions of the assigned study medication are given at later visits according to the study schedule. each infusion uses the same dose per kilogram as described for the first session. the exact timing of these visits is defined by the protocol and may occur every few weeks.

  6. Step 6

    Antiretroviral therapy interruption

    After the initial infusions, you stop taking your regular antiretroviral therapy (art) as instructed by the study. this period is called an art interruption. you are asked to attend frequent clinic visits for monitoring of viral load (the amount of hiv-1 RNA in the blood) and cd4+ t cell count.

  7. Step 7

    Regular monitoring visits

    You return to the clinic at specified weeks (for example, weeks 8, 14, 24, 36, and 60) or earlier if needed. at each visit, blood samples are collected to check viral load, cd4+ t cell count, and other safety laboratory values. any adverse events or side effects are recorded and evaluated.

  8. Step 8

    Possible restart of art

    If any of the following occurs, you will be instructed to restart antiretroviral therapy:

    1) six consecutive weeks with viral load greater than 1,000 copies per milliliter,

    2) confirmed viral load above 100,000 copies per milliliter,

    3) cd4+ t cell count falling below 350 cells per cubic millimeter on two consecutive tests,

    4) a request from you or a determination by the investigators that continuing the interruption poses an unacceptable risk.

    Restarting art is done promptly to protect your health.

Who can join the trial?

10 criteria

  • Be between 18 and 65 years old.
  • Agree to use barrier methods (such as condoms) during the time you stop your HIV medicines and until the virus is controlled again after you restart treatment.
  • Be able and willing to sign an informed consent form, which explains the study in detail.
  • Test negative for hepatitis B (HBV) and hepatitis C (HCV) infections, meaning no surface antigen, DNA, antigen, RNA, or core antibody indicating an active infection.
  • Have a current CD4 count higher than 500 cells per microliter, which shows a strong immune system.
  • Have a very low amount of HIV in the blood (plasma HIV‑1 RNA less than 50 copies per milliliter) for at least 15 months; a single test showing a slightly higher amount (between 50 and 500 copies) is allowed.
  • Be taking an HIV medicine that contains either an integrase inhibitor or a boosted protease inhibitor. If you were previously on a non‑nucleoside reverse transcriptase inhibitor (NNRTI), you must have switched to the new regimen at least 4 weeks before randomization.
  • Have an HIV‑1 reservoir that is predicted to be sensitive to the study antibody 10‑1074 based on genetic testing.
  • If you are a female who could become pregnant, you must not be post‑menopausal (you have had periods within the last 24 months and have not had a hysterectomy, removal of both ovaries, or removal of both fallopian tubes), and you must have a negative pregnancy test at screening, at the start of the study, during infusion visits, at the end of the study, and when you restart HIV medicines.
  • Agree to use a reliable method to prevent pregnancy throughout the study (60 weeks) and for 15 months after the antibody infusion: females must use condoms, hormonal birth control, an intra‑uterine device, or a hormone‑releasing intra‑uterine system; males must use condoms.

Who cannot join the trial?

17 criteria

  • Having a current or past serious heart disease, such as weak heart muscle, clogged arteries, heart failure, or a family history of a heart rhythm problem called long QT syndrome.
  • Having any type of cancer, except for skin cancers that are not melanoma.
  • Having received a solid organ transplant (replacement of a major organ like a kidney or liver).
  • Having an autoimmune disease (where the immune system attacks the body), including conditions such as type 1 diabetes, inflammatory bowel disease, scleroderma, severe psoriasis, heart inflammation, eye inflammation, lung inflammation, lupus, rheumatoid arthritis, optic nerve inflammation, myasthenia gravis, adrenal gland problems, thyroid problems (both underactive and overactive), thyroid autoimmunity, sarcoidosis, or vitiligo.
  • Being known to have resistance to more than two classes of antiretroviral therapy (ART) (medicines used to treat HIV).
  • Any other health problem that the study doctor thinks would make participation unsafe or could affect the study results.
  • Having an allergy (hypersensitivity) to any part of the study drugs 3BNC117‑LS, 10‑1074‑LS, or nivolumab.
  • Having an HIV‑1 strain called subtype CRF01‑AE that does not respond to the drug 10‑1074‑LS.
  • Having taken strong immune‑suppressing medicines or chemotherapy drugs within the last 28 days before screening.
  • Having certain lab test results outside normal ranges, including:
    • Kidney function measured by estimated glomerular filtration rate (eGFR)
    • Liver enzymes (AST or ALT) higher than 1.25 times the normal upper limit.
    • A positive Quantiferon test, which checks for tuberculosis infection.
    • Thyroid antibodies (TPO antibodies) greater than 35 IU/mL.
    • Being pregnant or breastfeeding (lactating).
    • Having received any vaccination within two weeks before the study start.
    • Having a recent serious infection (such as the flu or COVID‑19) or any other significant illness within two weeks before screening.
    • Having used a long‑acting HIV medicine (like cabotegravir or lenacaprivir) within the past 12 months.
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Investigated drugs

  • NIVOLUMAB

    is a medication that blocks a protein called PD‑1 on immune cells. By doing this, it can help the body’s immune system become more active. In this study a low dose of NIVOLUMAB is given together with other drugs to see if it can improve the body’s ability to keep HIV under control when treatment is stopped.

  • 3BNC117-LS

    is a long‑acting, laboratory‑made antibody that can recognize and neutralize many strains of HIV. It is given by infusion and stays in the body for an extended period, which may help keep the virus from growing during a break from regular HIV medication.

  • 10-1074-LS

    is another long‑acting, laboratory‑made antibody that targets a different part of the HIV virus. Like 3BNC117-LS, it is infused into the bloodstream and is designed to stay active for a long time, providing additional protection against the virus when standard HIV therapy is paused.

What is already known about the treatment

  • Nivolumab

    Given by intravenous infusion, it is a monoclonal antibody that blocks the PD‑1 protein on immune cells. It is an approved cancer drug but is still experimental for HIV treatment. It is mainly used to help the immune system fight tumors and, in this study, to boost immune control of HIV. It works by preventing PD‑1 from turning off immune responses, classifying it as an immune‑checkpoint inhibitor.

  • Sodium Chloride 0.9% Intravenous Infusion

    Delivered as a sterile solution for intravenous infusion, this isotonic saline is the standard fluid used to replace lost water and salts. It is an approved and widely used medical product with no specific disease‑treating claim in this trial, serving as the placebo. Its main purpose is to provide a neutral vehicle for the other drugs and to keep patients hydrated. It simply adds sodium and chloride ions to the bloodstream, placing it in the category of IV electrolyte solutions.

  • Teropavimab (3BNC117‑LS)

    Administered as an intravenous injection of a solution, this long‑acting antibody is still under investigation for HIV. It is a broadly neutralizing antibody that targets the HIV envelope protein, preventing the virus from entering cells. Its primary aim is to control HIV infection when antiretroviral therapy is stopped. By binding to a specific site on the virus, it blocks infection, and it is classified as a monoclonal antibody (broadly neutralizing).

  • 10‑1074‑LS

    Given by intravenous infusion of a solution, this long‑acting antibody is also experimental for HIV treatment. It is a broadly neutralizing antibody that recognizes a different region of the HIV envelope, stopping the virus from attaching to host cells. The drug is intended to maintain viral suppression during treatment interruption. Its action involves binding to the virus and blocking entry, and it belongs to the class of monoclonal broadly neutralizing antibodies.

Investigated diseases

Human immunodeficiency virus type 1 infection - It is a viral infection caused by HIV‑1 that targets the immune system, especially CD4+ T cells. Early after infection, people may experience flu‑like symptoms, followed by a period with few or no noticeable signs. Over months to years, the virus gradually lowers the number of CD4+ cells, reducing the body’s ability to fight other germs. As the CD4 count falls, infections that are normally rare can appear more often. Without control, the infection becomes chronic and persists in the bloodstream.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-523725-17-00Protocol codeIDUNN-001Estimated enrolment95 patientsSponsorRegion Midtjylland

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