Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Switching to Lenacapavir, Teropavimab, and Zinlirvimab in Virologically Suppressed Adults with HIV-1: A Phase 3 Randomized Study

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

The study focuses on adults living with HIV-1 who already have the virus under control with daily oral medicines. The new approach replaces those pills with an injection given twice a year that contains three agents: lenacapavir, a medication that blocks the virus’s protective shell (the capsid); teropavimab and zinlirvimab, which are lab‑made antibodies that attach to the virus and prevent it from infecting cells.

The purpose of the study is to see whether switching to this injection regimen keeps the virus suppressed as well as continuing the usual oral pills. Participants will receive the injection at the start of the study and then every six months, while regular clinic visits will collect blood samples to check the amount of virus, the number of CD4+ T‑cells (a type of immune cell that helps fight infections), and any changes in health over about two years.

Throughout the trial, safety will be closely watched. Any side effects or problems will be recorded, and participants may stop the study medication if serious issues arise. Blood tests will also measure how much of the new drugs remain in the body and whether the body develops any antibodies against them.

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

    Baseline visit and first dosing

    At week 0 you attend the clinic after enrollment. you stop your previous oral HIV medication and start the study regimen.

    You take lenacapavir 600 mg as an oral tablet. the dose is taken once and will be repeated every 24 weeks (twice a year).

    You receive teropavimab 3400 mg and zinlirvimab 3400 mg as intravenous infusions. the infusions are given together during this visit and will be repeated every 24 weeks.

    Blood is drawn to measure your hiv‑1 viral load (the amount of virus in the blood), cd4+ t‑cell count (a measure of immune health), and baseline safety labs.

  2. Step 2

    First safety follow‑up

    At week 4 you return to the clinic for a safety check.

    You report any side effects or health changes that occurred since the baseline visit.

    A blood sample is taken to re‑measure viral load and cd4+ t‑cell count.

  3. Step 3

    Second safety follow‑up

    At week 12 you have another clinic visit.

    The same safety assessments are performed: reporting of adverse events and blood draws for viral load and cd4+ t‑cell count.

  4. Step 4

    Mid‑study visit and drug‑level check

    At week 26 you attend a scheduled visit.

    Blood is drawn to determine trough concentrations of lenacapavir, teropavimab, and zinlirvimab (the lowest level of drug in the blood before the next dose).

    Viral load, cd4+ t‑cell count, and safety labs are also repeated.

    Any adverse events are recorded.

  5. Step 5

    Primary efficacy assessment and second dosing

    At week 52 you have a major study visit.

    You receive the second dose of lenacapavir 600 mg orally and a second intravenous infusion of teropavimab 3400 mg plus zinlirvimab 3400 mg.

    Blood is taken to assess hiv‑1 viral load, cd4+ t‑cell count, and trough drug concentrations.

    The primary outcome of the study – the proportion of participants with viral load ≥ 50 copies/ml – is evaluated at this point.

    All adverse events since the last visit are documented.

  6. Step 6

    Interim safety visit

    At week 68 you return for a safety visit.

    You report any new symptoms, and blood is drawn for viral load, cd4+ t‑cell count, and routine safety labs.

  7. Step 7

    Secondary efficacy assessment

    At week 92 you attend a clinic visit for the secondary efficacy assessment.

    Viral load and cd4+ t‑cell count are measured, and adverse events are recorded.

    The study evaluates the proportion of participants with viral load ≥ 50 copies/ml and the proportion with viral load < 50 copies/ml at this time point.

  8. Step 8

    Final visit and study completion

    At week 104 you complete the study.

    You receive the third dose of lenacapavir 600 mg orally (if required by the protocol) and the final intravenous infusions of teropavimab 3400 mg and zinlirvimab 3400 mg.

    Blood is drawn for final viral load, cd4+ t‑cell count, and trough concentrations of all study drugs.

    All remaining safety information and adverse events are collected, and the study treatment is discontinued.

Who can join the trial?

10 criteria

  • You must be assigned male or female at birth and be 18 years or older.
  • You must be able to understand the study information, sign a written consent form, and follow the study visits and medication schedule.
  • If you were assigned female at birth, can become pregnant, and have heterosexual sex, you must agree to use the birth‑control method required by the study.
  • Your body weight must be at least 35 kilograms (about 77 pounds) at the screening visit.
  • A lab test must show that the HIV virus in your body is sensitive to the two study drugs called TAB and ZAB. This is measured by a special test that looks at how well the drugs work against the virus.
  • Your blood test for HIV (called viral load) must show fewer than 50 copies of the virus per milliliter at screening, which means the virus is undetectable.
  • You need to have at least one viral‑load test done between 6 and 12 months before screening, and all those tests must also show fewer than 50 copies/mL. A single small rise (called a “blip”) up to 400 copies/mL is allowed if the next test is again below 50.
  • You must have a viral‑load test showing fewer than 50 copies/mL within the six months before the earlier test, and if you have more than one test in that period, all must be below 50 copies/mL.
  • You must have been taking a stable oral ART (antiretroviral therapy) regimen for at least six months before screening, and you cannot change that regimen during the screening period.
  • If you could become pregnant, you must have a negative pregnancy test at screening and again on the day you start the study medication.

Who cannot join the trial?

24 criteria

  • Having had an opportunistic infection (an infection that occurs when the immune system is weak) or any illness that shows the HIV is in Stage 3.
  • Previously using or being exposed to LEN or a bNAb (a special type of antibody that attacks many forms of HIV) for HIV‑1.
  • Previously using or being exposed to the HIV medicines ibalizumab, fostemsavir, or maraviroc.
  • Being on a treatment plan that includes only one antiretroviral drug (called monotherapy) at the start of the study.
  • Having taken immune‑suppressing medicines (such as corticosteroids, immunoglobulins, or other drugs that lower the immune response) within 4 weeks before screening, unless it was a short course of corticosteroids lasting 7 days or less, or needing ongoing immune‑suppressing treatment during the study.
  • Using any medication that is listed as prohibited for the study, either now or in the past.
  • Being enrolled in, or planning to join, another clinical study without the sponsor’s permission.
  • Previously using or being exposed to long‑acting injectable forms of cabotegravir (LA CAB) or rilpivirine (LA RPV).
  • Currently using or having been exposed to the HIV drugs nevirapine or zidovudine.
  • Testing positive for hepatitis C antibodies and having detectable hepatitis C virus (HCV) RNA, indicating an active hepatitis C infection.
  • Having chronic hepatitis B infection, shown by a positive hepatitis B surface antigen with a negative surface antibody, or a positive core antibody with a negative surface antibody.
  • Being known to have an allergy (hypersensitivity) to the study drug, its breakdown products, or any of its ingredients.
  • Having severe kidney problems, defined as an estimated glomerular filtration rate (eGFR) less than 30 mL/min, which means the kidneys are not filtering blood well.
  • Having an abnormal electrocardiogram (ECG) result that the doctor considers clinically important.
  • Having any of the following lab results at screening: ALT (a liver enzyme) more than five times the normal limit; direct bilirubin more than 1.5 times the normal limit; platelet count less than 50,000 per mm³; or hemoglobin less than 8.0 g/dL (a measure of red blood cells).
  • Having other medical or psychiatric conditions, or previous treatments, that the investigator believes could interfere with the study, make it hard to finish study visits, or create too much risk.
  • Being under guardianship, curatorship, or other legal protection that limits the ability to give consent.
  • Having an active, serious infection (other than HIV) that needed treatment within the 30 days before randomization.
  • Having an active tuberculosis (TB) infection.
  • Having acute hepatitis of any cause within the 30 days before randomization.
  • Having a history of, or current, severe liver disease such as decompensated cirrhosis (e.g., fluid buildup in the abdomen, brain changes, or bleeding from enlarged veins) or severe hepatic impairment classified as Child‑Pugh Class C.
  • Having an active cancer that requires immediate systemic (body‑wide) therapy.
  • Having poor vein access that would make it difficult to draw blood or give an IV infusion of the study drugs.
  • Being assigned female at birth and currently pregnant, breastfeeding, planning to become pregnant, or planning to start breastfeeding during the study.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

RecruitingNot yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Lenacapavir

    is a new type of HIV medicine that blocks the virus’s capsid, a protein shell that protects the virus’s genetic material. In this study it is given as a pill or injection twice a year to see if it can keep the virus suppressed when used with other drugs.

  • Teropavimab

    is a broadly neutralizing antibody that is given by IV infusion. It works by attaching to HIV and preventing it from infecting cells. The trial tests whether adding this antibody to the regimen helps maintain viral suppression.

  • Zinlirvimab

    is another broadly neutralizing antibody administered by IV infusion. Like teropavimab, it targets HIV directly and blocks the virus from entering cells. The study evaluates its combined effect with lenacapavir and teropavimab.

  • Cobicistat

    is a booster medication that increases the levels of other HIV drugs in the body. In the trial participants who stay on their usual oral regimen continue to take cobicistat as part of their combination therapy.

  • Dolutegravir

    is an integrase inhibitor that stops HIV from inserting its genetic material into human cells. It is one of the standard drugs used by participants who remain on their usual oral treatment.

  • Etravirine

    belongs to a class called non‑nucleoside reverse transcriptase inhibitors (NNRTIs). It blocks an enzyme the virus needs to make copies of its RNA. Participants on the standard regimen may be taking etravirine.

What is already known about the treatment

  • Tybost 150 mg film-coated tablets

    This medication is taken by mouth as a film‑coated tablet. Cobicistat is a booster that is used to increase the level of other HIV drugs in the body and is approved for use in combination HIV therapy. It works by blocking a liver enzyme that would otherwise break down the partner drugs. It belongs to the pharmacokinetic enhancer class.

  • Tivicay 50 mg film-coated tablets

    Dolutegravir is swallowed as a film‑coated tablet. It is an approved HIV medicine that is part of standard treatment regimens. The drug stops the virus from inserting its genetic material into human cells by blocking the integrase enzyme. It is classified as an integrase strand transfer inhibitor.

  • INTELENCE 200 mg tablets

    Etravirine is taken orally as a tablet. It is an approved drug for treating HIV‑1 infection, often used when other medicines do not work well. It prevents the virus from copying itself by binding to the reverse‑transcriptase enzyme. It belongs to the non‑nucleoside reverse transcriptase inhibitor (NNRTI) class.

  • Sunlenca 464 mg solution for injection

    Lenacapavir is given as an injection solution that can also be taken orally in other forms. It is a newer HIV drug that has received regulatory approval and is being studied in clinical trials. The medication blocks the viral capsid, stopping the virus from assembling and entering cells. It is classified as a capsid inhibitor.

  • Sunlenca 300 mg film-coated tablets

    Lenacapavir is also available as a film‑coated tablet taken by mouth twice a year. It is an approved long‑acting HIV treatment under investigation for extended dosing schedules. It works by binding to the HIV capsid protein, preventing the virus from completing its life cycle. It belongs to the capsid inhibitor class.

  • Emtriva 200 mg hard capsules

    Emtricitabine comes in hard capsules that are swallowed. It is an approved component of many HIV combination therapies. The drug mimics a natural building block of DNA, causing the virus to stop copying its genetic material. It is a nucleoside reverse transcriptase inhibitor (NRTI).

Investigated diseases

Human immunodeficiency virus infection - It is a viral condition caused by HIV type 1 that enters and multiplies in cells of the immune system. Over time the virus lowers the number of important immune cells, making it harder for the body to fight everyday germs. As the infection continues, the immune protection slowly weakens, which can allow more frequent and longer-lasting infections to appear.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524336-19-00Protocol codeGS-US-536-6544Estimated enrolment590 patientsSponsorGilead Sciences Inc.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.