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Switching to Lenacapavir-based drug combination vs cabotegravir-based drug combination in virologically suppressed adults with HIV-1

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What is this trial about?

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

This study looks at adults with HIV-1 whose virus is already well controlled with daily pills. It compares a new long‑acting regimen that combines two antibodies, teropavimab and zinlirvimab, given by intravenous infusion (a drip into a vein), with a drug that blocks a part of the virus called the capsid, lenacapavir, given under the skin (subcutaneous) or as a tablet. The comparison regimen uses two existing long‑acting medicines, cabotegravir and rilpivirine, which are injected into the muscle (intramuscular) every eight weeks.

The purpose of the study is to see whether switching to the antibody‑plus‑capsid‑inhibitor regimen keeps the virus suppressed as well as the standard long‑acting injectables. Participants will receive their assigned injections or tablets on a set schedule for about two years, with regular clinic visits to check health, simple blood tests, and any side effects.

After an initial screening, participants start the assigned treatment, receive the first dose in the clinic, and then return at predetermined intervals for repeat doses and basic blood checks. Throughout the study, doctors will watch for common side effects and will measure immune cell numbers to ensure safety.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline visit and randomization

    You will attend a baseline appointment where personal health information, a physical exam, and blood tests will be performed. the blood tests will include measurement of hiv viral load (the amount of hiv virus in your blood) and cd4+ t‑cell count (a measure of immune system health).

    After the baseline assessments, you will be randomly assigned to one of two treatment groups.

  2. Step 2

    First dosing visit

    If you are assigned to the long‑acting antibody group, you will receive three injections on the same day: a subcutaneous injection of lenacapavir 600 mg, an intravenous infusion of teropavimab 3400 mg, and an intravenous infusion of zinlirvimab 3400 mg. these medications are given as a single dose that will provide protection for approximately six months.

    If you are assigned to the comparator group, you will receive two intramuscular injections on the same day: cabotegravir 3400 mg and rilpivirine 900 mg. these injections are scheduled to be repeated every eight weeks.

  3. Step 3

    Regular dosing schedule

    For the antibody group, you will return for the same set of three injections every 24 weeks (approximately twice a year) for the duration of the study.

    For the comparator group, you will receive the two intramuscular injections every eight weeks (about every two months) for the duration of the study.

  4. Step 4

    Routine follow‑up visits

    You will attend clinic visits at weeks 4, 12, 24, 26, 52, 72, 92, and 104. at each visit, blood will be drawn to check hiv viral load, cd4+ t‑cell count, and routine safety labs. you will also be asked about any side effects or new health problems.

    The study staff will record any adverse events (any unwanted medical problem that occurs during the study) and will assess whether the study medication needs to be adjusted or stopped.

  5. Step 5

    Drug concentration monitoring

    Additional blood samples will be taken at weeks 26, 52, and 104 to measure the levels of lenacapavir, teropavimab, and zinlirvimab in your bloodstream. this helps determine how the drugs are maintained over time.

  6. Step 6

    Final study visit

    At week 104, you will complete the final study visit. this visit includes the same laboratory assessments as earlier visits, a review of any adverse events that occurred during the study, and a discussion of the overall results.

  7. Step 7

    Possible early discontinuation

    If a serious adverse event occurs or if you develop a condition that makes continued use of the study medication unsafe, the study medication may be stopped before the scheduled end of the study. you will be monitored closely and provided appropriate medical care.

Who can join the trial?

9 criteria

  • Be 18 years of age or older, assigned male or female at birth, able to understand the study information and give written consent, and able to follow the study visits and medication schedule.
  • If you were assigned female at birth, are able to become pregnant, and have heterosexual intercourse, you must agree to use the birth‑control method required by the study.
  • Weigh at least 35 kg (about 77 lb) at the screening visit.
  • Your HIV‑1 virus must be shown to be sensitive (responsive) to the medicines TAB and ZAB, meaning a laboratory test called IC90 is 2 µg/mL or lower for each drug.
  • Your blood test for HIV‑1 (called viral load) must show fewer than 50 copies of the virus per milliliter at the screening visit.
  • You must have at least one viral load test done between 6 and 12 months before screening, and that test (and any others in that period) must also be below 50 copies/mL. One brief increase (“blip”) to between 50 and 400 copies/mL is allowed if the next test is back below 50 copies/mL.
  • You must have a viral load test showing fewer than 50 copies/mL within the 6 months before the earlier test; if you have more than one test in that time, all must be below 50 copies/mL.
  • You must have been taking a stable oral HIV medicine regimen (ART) for at least 6 months before screening, with no changes to the regimen after the earlier test.
  • If you could become pregnant, you must have a negative pregnancy test at screening and again on the first day of the study before taking any study medication.

Who cannot join the trial?

29 criteria

  • History of opportunistic infection (an infection that happens when the immune system is very weak) or any illness that indicates Stage 3 HIV disease.
  • Active malignancy (cancer) that needs immediate systemic (whole‑body) treatment.
  • Poor venous access, meaning it is difficult to draw blood or give an IV infusion for the study drugs.
  • Pregnancy or breastfeeding, or planning to become pregnant or start breastfeeding during the study.
  • Previous use or exposure to LEN or a broadly neutralizing antibody (bNAb) for HIV‑1.
  • Previous use or exposure to the long‑acting injectable drugs CAB or RPV.
  • Previous use or exposure to the HIV medicines ibalizumab, fostemsavir, or maraviroc.
  • Being on a monotherapy regimen (taking only one antiretroviral drug) at the start of the study.
  • Use of immunosuppressant therapies (medicines that lower the immune system, such as corticosteroids, immunoglobulins, or other immune‑targeting drugs) within the past 4 weeks, except for a short course of steroids lasting 7 days or less, or a condition that requires ongoing immune‑suppressing treatment.
  • Use of any prohibited medications listed in the study protocol.
  • Participation in, or planned participation in, another clinical study without the sponsor’s approval.
  • History of treatment failure (previous HIV treatment that did not keep the virus under control).
  • Positive test for hepatitis C antibody **and** detectable hepatitis C virus (HCV) RNA, indicating active hepatitis C infection.
  • Chronic hepatitis B infection, identified by either a positive hepatitis B surface antigen with a negative surface antibody, or a positive core antibody with a negative surface antibody.
  • Severe kidney impairment (estimated glomerular filtration rate < 30 mL/min), meaning the kidneys are not working well.
  • A clinically significant abnormal electrocardiogram (ECG) at screening, indicating a heart rhythm or electrical problem.
  • Any of the following lab results at screening:
    • ALT (liver enzyme) more than 5 times the normal upper limit.
    • Direct bilirubin more than 1.5 times the normal upper limit.
    • Platelet count less than 50,000 per mm³.
    • Hemoglobin less than 8.0 g/dL (low blood oxygen‑carrying protein).
    • Other medical or psychiatric conditions, or prior therapies, that the investigator believes could interfere with the study, make it hard to complete study visits, or pose an undue risk.
    • Being under legal guardianship, curatorship, or other legal protection, which prevents independent consent.
    • Known or suspected resistance to CAB or RPV (the virus has genetic changes that make these drugs less effective).
    • A skin condition or implanted prosthesis (such as a device) over the buttock area where the study injections would be given.
    • Known hypersensitivity (allergy) to the study drug, its breakdown products, or any of its ingredients.
    • Active, serious infections (other than HIV) that required treatment within the past 30 days.
    • Active tuberculosis infection.
    • Acute hepatitis of any cause (sudden liver inflammation) within the past 30 days.
    • History of, or current, decompensated liver cirrhosis (severe liver disease with complications such as fluid buildup, brain changes, or bleeding) or severe liver impairment classified as Child‑Pugh Class C.
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Investigated drugs

  • Zinlirvimab

    is a laboratory‑made antibody that binds to HIV and helps the immune system neutralize the virus. In this study it is given by intravenous infusion and is used together with another antibody as part of the experimental long‑acting treatment.

  • Teropavimab

    is another laboratory‑made antibody that targets HIV. It is also administered by intravenous infusion and is combined with Zinlirvimab to provide a broad‑spectrum attack on the virus in the experimental regimen.

  • Lenacapavir

    is a medication that blocks a key part of the HIV virus called the capsid, preventing the virus from forming new copies. It is given as a subcutaneous injection (under the skin) and is taken only twice a year as part of the new long‑acting therapy.

  • Cabotegravir

    is an HIV medicine that stops the virus from inserting its genetic material into human cells. It is formulated as a long‑acting suspension that is injected into a muscle and is given every eight weeks in the standard comparator regimen.

  • Rilpivirine

    is a medication that interferes with the HIV enzyme needed to copy its genetic code. Like Cabotegravir, it is provided as a long‑acting muscle injection and is administered every eight weeks as part of the comparator treatment.

What is already known about the treatment

  • Zinlirvimab

    Given as an intravenous infusion solution, this monoclonal antibody is still under clinical investigation and not yet approved for general use. It is designed to treat HIV‑1 infection by binding to the virus’s outer envelope protein, blocking the virus from entering human cells. Its action belongs to the class of broadly neutralizing antibodies that target viral entry.

  • Lenacapavir

    Available as a subcutaneous injection solution and also as a film‑coated oral tablet, lenacapavir is an FDA‑approved capsid inhibitor for HIV‑1 treatment. It works by attaching to the viral capsid protein, preventing the virus from assembling and replicating inside cells. This drug is classified as a capsid assembly inhibitor, a new class of antiretroviral agents.

  • Teropavimab

    Administered by intravenous infusion, teropavimab is an investigational broadly neutralizing antibody still being studied for HIV‑1 therapy. It neutralizes the virus by binding to the envelope glycoprotein, stopping the virus from fusing with and entering host cells. It falls under the category of antiviral monoclonal antibodies aimed at viral entry inhibition.

  • Cabotegravir

    Delivered as a long‑acting intramuscular injection suspension, cabotegravir is an approved integrase strand‑transfer inhibitor used for HIV‑1 infection. It blocks the integrase enzyme, preventing the virus from inserting its genetic material into the host cell’s DNA. This medication belongs to the class of integrase inhibitors and is used in maintenance therapy for HIV‑1.

  • Rilpivirine

    Provided as a prolonged‑release intramuscular injection suspension, rilpivirine is an approved non‑nucleoside reverse transcriptase inhibitor for HIV‑1 treatment. It binds to the reverse transcriptase enzyme, stopping the virus from copying its RNA into DNA. It is classified as an NNRTI and is used as part of combination antiretroviral regimens.

Investigated diseases

Human immunodeficiency virus type 1 infection - It is a viral infection that targets the body's immune system, especially the cells that help fight other germs. Over time the virus lowers the number of these immune cells, making it harder for the body to control everyday infections. The infection usually starts with few or no symptoms, then progresses to more frequent colds, fevers, and swollen glands. As the immune cells continue to decline, common infections may become more persistent and harder to clear. The virus remains in the body for life, and its activity can change from periods of low activity to higher levels without treatment.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524335-39-00Protocol codeGS-US-536-5938Estimated enrolment590 patientsSponsorGilead Sciences Inc.

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