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New drug aims to clear hepatitis b in HIV patients

NCT ID NCT06497504

Disease control Sponsor: GlaxoSmithKline Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 09, 2026 · Updated 2 times

Summary

This study tests a new drug called bepirovirsen in 153 people who have both HIV and chronic hepatitis B and are already on HIV treatment. The goal is to see if bepirovirsen can clear the hepatitis B virus from the body better than a placebo. Participants will continue their regular HIV medications throughout the study.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

153 people

The number who actually took part.

Started

Sep 2024

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Documented chronic hepatitis B virus (HBV) infection and documented human immunodeficiency virus (HIV)-1 infection greater than equal to (\>=) 12 months prior to Screening. 2. Must be on uninterrupted antiretroviral therapy (ART) containing at least tenofovir disoproxil (TDF) or tenofovir alafenamide (TAF) plus lamivudine (3TC) or emtricitabine (FTC) for greater than (\>)12 months, with no planned changes to the stable regimen over the duration of the study. o Switch in ART is permitted \>=6 months prior to Screening for reasons not related to loss of HIV or HBV control (e.g., change in formulary, tolerability, side effects). 3. Documented evidence of at least 2 plasma HIV-1 ribonucleic acid (RNA) measurements less than (\<) 50 copies per milliliter (copies/mL) are required in the 12 months prior to Screening: 1 within 6 to 12 months prior to Screening and 1 within 6 months prior to Screening. 4. Plasma or serum HBV deoxyribonucleic acid (DNA) concentration must be adequately suppressed, defined as plasma or serum HBV DNA \<90 international units per milliliter (IU/mL). 5. Plasma or serum HBsAg concentration \>100 IU/mL and \<=3000 IU/mL. 6. Plasma HIV-1 RNA concentration must be undetectable, defined as plasma HIV 1 RNA \<50 copies/mL. 7. Cluster of differentiation 4 (CD4) count \>=350 cells per cubic millimeter (cells/mm\^3). 8. Alanine aminotransferase (ALT) \<=2 times upper limit of normal (ULN). Exclusion Criteria: 1. History of or suspected liver cirrhosis and/or evidence of cirrhosis. 2. Diagnosed or suspected hepatocellular carcinoma (HCC). 3. History of extrahepatic disorders possibly related to HBV immune conditions (e.g., nephrotic syndrome, any type of glomerulonephritis, polyarteritis nodosa, cryoglobulinemia, uncontrolled hypertension). 4. Coinfection with: 1. Hepatitis C virus (HCV) with positive HCV antibody and detectable HCV RNA at Screening. I. HCV treatment should have completed \>12 months prior to Screening. 2. Hepatitis D virus (HDV) defined as positive or equivocal HDV antibody regardless of HDV RNA level. 5. Clinically significant abnormalities, aside from HIV-1 infection and chronic HBV infection in medical history (e.g., moderate severe liver disease other than chronic HBV/HIV, acute coronary syndrome within 6 months of Screening, major surgery within 3 months of Screening, significant/unstable cardiac disease, uncontrolled diabetes, bleeding diathesis coagulopathy) or clinically significant physical examination findings. 6. Untreated syphilis infection (positive rapid plasma reagin \[RPR\] at Screening without clear documentation of treatment) are excluded unless they complete treatment during the Screening period and 7 days prior to randomization. 7. History of malignancy within the past 5 years with the exception of specific cancers that are cured by surgical resection (e.g., skin cancer). Participants under evaluation for possible malignancy are not eligible. 8. History of vasculitis or presence of symptoms and signs of potential vasculitis (e.g., vasculitic rash, skin ulceration, repeated blood detected in urine without identified cause), current or history of an autoimmune condition or history/presence of other diseases that may be associated with vasculitis condition (e.g., systemic lupus erythematosus, rheumatoid arthritis, relapsing polychondritis, mononeuritis multiplex). 9. Participants who in the investigator's judgment, have a significant risk of suicide or self-harm. 10. Alcohol or drug abuse/dependence 11. Currently taking, or took within 3 months of Screening, any immunosuppressing drugs (e.g., prednisone), other than a short course of therapy (\<=2 weeks) or topical/inhaled steroid use. 12. Participants to whom immunosuppressive treatment, including therapeutic doses of steroids, is contraindicated should not be considered for enrolment in the study. 13. Currently taking, or has taken within 12 months of Screening, any interferon containing therapy. 14. Participants requiring anti coagulation therapies (e.g., warfarin, Factor Xa inhibitors) or anti platelet agents (including but not limited to clopidogrel or aspirin) unless treatment can safely be discontinued throughout duration of study intervention, by the discretion of the investigator. Occasional use is permitted. 15. Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening. 16. Prior treatment with any oligonucleotide or small interfering ribonucleic acid (siRNA) within 12 months prior to the first dosing day. 17. Prior treatment with bepirovirsen.

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Conditions

The condition(s) this trial relates to.

AIDS chronic hepatitis B virus infection hepatitis B virus infection HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hepatitis B

Contacts and locations

Locations

  • GSK Investigational Site

    Bakersfield, California, 93301, United States

  • GSK Investigational Site

    San Francisco, California, 94115, United States

  • GSK Investigational Site

    Orlando, Florida, 32803, United States

  • GSK Investigational Site

    West Palm Beach, Florida, 33409, United States

  • GSK Investigational Site

    Baltimore, Maryland, 21287, United States

  • GSK Investigational Site

    Minneapolis, Minnesota, 55415, United States

  • GSK Investigational Site

    Hillsborough, New Jersey, 08844, United States

  • GSK Investigational Site

    Almagro, C1427CEA, Argentina

  • GSK Investigational Site

    Buenos Aires, 1023, Argentina

  • GSK Investigational Site

    Buenos Aires, C1181ACI, Argentina

  • GSK Investigational Site

    Buenos Aires, C1425AGC, Argentina

  • GSK Investigational Site

    La Plata, B1900AVG, Argentina

  • GSK Investigational Site

    Rosario, S2002KDR, Argentina

  • GSK Investigational Site

    Aracaju, 49060-010, Brazil

  • GSK Investigational Site

    Campinas, 13034-685, Brazil

  • GSK Investigational Site

    Curitiba, 80810-050, Brazil

  • GSK Investigational Site

    Manaus, 69040-000, Brazil

  • GSK Investigational Site

    Salvador, 40110-060, Brazil

  • GSK Investigational Site

    São Paulo, 04121-000, Brazil

  • GSK Investigational Site

    Ottawa, Ontario, K1H 8L6, Canada

  • GSK Investigational Site

    Toronto, Ontario, M5G 1K2, Canada

  • GSK Investigational Site

    Montreal, Quebec, H2L 4P9, Canada

  • GSK Investigational Site

    Montreal, Quebec, H4A 3J1, Canada

  • GSK Investigational Site

    Québec, Quebec, G1V 4G2, Canada

  • GSK Investigational Site

    Marseille, 13003, France

  • GSK Investigational Site

    Melun, 77000, France

  • GSK Investigational Site

    Montpellier, 34295, France

  • GSK Investigational Site

    Nantes, 44093, France

  • GSK Investigational Site

    Paris, 75012, France

  • GSK Investigational Site

    Paris, 75018, France

  • GSK Investigational Site

    Genova, 16132, Italy

  • GSK Investigational Site

    Milan, 20157, Italy

  • GSK Investigational Site

    Milan, 20162, Italy

  • GSK Investigational Site

    Naples, 80131, Italy

  • GSK Investigational Site

    Roma, 00153, Italy

  • GSK Investigational Site

    Sassari, 07100, Italy

  • GSK Investigational Site

    Durban, KwaZulu-Natal, 4052, South Africa

  • GSK Investigational Site

    Ekurhuleni, 1459, South Africa

  • GSK Investigational Site

    Johannesburg, 2092, South Africa

  • GSK Investigational Site

    Barcelona, 08036, Spain

  • GSK Investigational Site

    Córdoba, 14004, Spain

  • GSK Investigational Site

    Madrid, 28032, Spain

  • GSK Investigational Site

    Madrid, 28040, Spain

  • GSK Investigational Site

    Madrid, 28041, Spain

  • GSK Investigational Site

    Madrid, 28046, Spain

  • GSK Investigational Site

    Banchiau Taipei, 220, Taiwan

  • GSK Investigational Site

    Kaohsiung City, 813, Taiwan

  • GSK Investigational Site

    Bristol Avon, BS10 5NB, United Kingdom

  • GSK Investigational Site

    London, E1 1BB, United Kingdom

  • GSK Investigational Site

    London, NW3 2QG, United Kingdom

  • GSK Investigational Site

    London, SE5 9RS, United Kingdom

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