Phase
Condition
Hepatitis
Hiv Infections
Hepatitis B
Treatment
Placebo
Bepirovirsen
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Documented chronic hepatitis B virus (HBV) infection and documented humanimmunodeficiency virus (HIV)-1 infection greater than equal to (>=) 12 months priorto Screening.
Must be on uninterrupted antiretroviral therapy (ART) containing at least tenofovirdisoproxil (TDF) or tenofovir alafenamide (TAF) plus lamivudine (3TC) oremtricitabine (FTC) for greater than (>)12 months, with no planned changes to thestable regimen over the duration of the study. o Switch in ART is permitted >=6 months prior to Screening for reasons not relatedto loss of HIV or HBV control (e.g., change in formulary, tolerability, sideeffects).
Documented evidence of at least 2 plasma HIV-1 ribonucleic acid (RNA) measurementsless than (<) 50 copies per milliliter (copies/mL) are required in the 12 monthsprior to Screening: 1 within 6 to 12 months prior to Screening and 1 within 6 monthsprior to Screening.
Plasma or serum HBV deoxyribonucleic acid (DNA) concentration must be adequatelysuppressed, defined as plasma or serum HBV DNA <90 international units permilliliter (IU/mL).
Plasma or serum HBsAg concentration >100 IU/mL and <=3000 IU/mL.
Plasma HIV-1 RNA concentration must be undetectable, defined as plasma HIV 1 RNA <50copies/mL.
Cluster of differentiation 4 (CD4) count >=350 cells per cubic millimeter (cells/mm^3).
Alanine aminotransferase (ALT) <=2 times upper limit of normal (ULN).
Exclusion
Exclusion Criteria:
History of or suspected liver cirrhosis and/or evidence of cirrhosis.
Diagnosed or suspected hepatocellular carcinoma (HCC).
History of extrahepatic disorders possibly related to HBV immune conditions (e.g.,nephrotic syndrome, any type of glomerulonephritis, polyarteritis nodosa,cryoglobulinemia, uncontrolled hypertension).
Coinfection with:
Hepatitis C virus (HCV) with positive HCV antibody and detectable HCV RNA atScreening. I. HCV treatment should have completed >12 months prior to Screening.
Hepatitis D virus (HDV) defined as positive or equivocal HDV antibodyregardless of HDV RNA level.
Clinically significant abnormalities, aside from HIV-1 infection and chronic HBVinfection in medical history (e.g., moderate severe liver disease other than chronicHBV/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 examinationfindings.
Untreated syphilis infection (positive rapid plasma reagin [RPR] at Screeningwithout clear documentation of treatment) are excluded unless they completetreatment during the Screening period and 7 days prior to randomization.
History of malignancy within the past 5 years with the exception of specific cancersthat are cured by surgical resection (e.g., skin cancer). Participants underevaluation for possible malignancy are not eligible.
History of vasculitis or presence of symptoms and signs of potential vasculitis (e.g., vasculitic rash, skin ulceration, repeated blood detected in urine withoutidentified cause), current or history of an autoimmune condition or history/presenceof other diseases that may be associated with vasculitis condition (e.g., systemiclupus erythematosus, rheumatoid arthritis, relapsing polychondritis, mononeuritismultiplex).
Participants who in the investigator's judgment, have a significant risk of suicideor self-harm.
Alcohol or drug abuse/dependence
Currently taking, or took within 3 months of Screening, any immunosuppressing drugs (e.g., prednisone), other than a short course of therapy (<=2 weeks) ortopical/inhaled steroid use.
Participants to whom immunosuppressive treatment, including therapeutic doses ofsteroids, is contraindicated should not be considered for enrolment in the study.
Currently taking, or has taken within 12 months of Screening, any interferoncontaining therapy.
Participants requiring anti coagulation therapies (e.g., warfarin, Factor Xainhibitors) or anti platelet agents (including but not limited to clopidogrel oraspirin) unless treatment can safely be discontinued throughout duration of studyintervention, by the discretion of the investigator. Occasional use is permitted.
Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.
Prior treatment with any oligonucleotide or small interfering ribonucleic acid (siRNA) within 12 months prior to the first dosing day.
Prior treatment with bepirovirsen.
Study Design
Connect with a study center
GSK Investigational Site
Almagro, C1427CEA
ArgentinaActive - Recruiting
GSK Investigational Site
Buenos Aires, C1181ACI
ArgentinaActive - Recruiting
GSK Investigational Site
La Plata, B1900AVG
ArgentinaActive - Recruiting
GSK Investigational Site
Rosario, S2002KDR
ArgentinaActive - Recruiting
GSK Investigational Site
Aracaju, 49060-010
BrazilActive - Recruiting
GSK Investigational Site
Campinas, 13034-685
BrazilActive - Recruiting
GSK Investigational Site
Curitiba, 80810-050
BrazilActive - Recruiting
GSK Investigational Site
Manaus, 69040-000
BrazilSite Not Available
GSK Investigational Site
SAo Paulo, 04121-000
BrazilActive - Recruiting
GSK Investigational Site
Salvador, 40110-060
BrazilActive - Recruiting
GSK Investigational Site
Ottawa, Ontario K1H 8L6
CanadaActive - Recruiting
GSK Investigational Site
Toronto, Ontario M5G 1K2
CanadaActive - Recruiting
GSK Investigational Site
Montreal, Quebec H4A 3J1
CanadaActive - Recruiting
GSK Investigational Site
Quebec City, Quebec G1V 4G2
CanadaActive - Recruiting
GSK Investigational Site
Québec, G1V 4G2
CanadaSite Not Available
GSK Investigational Site
Marseille, 13003
FranceActive - Recruiting
GSK Investigational Site
Melun, 77000
FranceActive - Recruiting
GSK Investigational Site
Montpellier Cedex 5, 34295
FranceActive - Recruiting
GSK Investigational Site
Nantes cedex 1, 44093
FranceActive - Recruiting
GSK Investigational Site
Paris, 75018
FranceActive - Recruiting
GSK Investigational Site
Firenze, 50134
ItalyActive - Recruiting
GSK Investigational Site
Genova, 16132
ItalyActive - Recruiting
GSK Investigational Site
Milano, 20157
ItalyActive - Recruiting
GSK Investigational Site
Napoli, 80131
ItalyActive - Recruiting
GSK Investigational Site
Roma, 00153
ItalySite Not Available
GSK Investigational Site
Sassari, 07100
ItalyActive - Recruiting
GSK Investigational Site
Boksburg, Gauteng 1459
South AfricaSite Not Available
GSK Investigational Site
Cape Town, 7925
South AfricaSite Not Available
GSK Investigational Site
Durban, 4052
South AfricaActive - Recruiting
GSK Investigational Site
Johannesburg, 2092
South AfricaActive - Recruiting
GSK Investigational Site
Observatory, Cape Town, 7925
South AfricaSite Not Available
GSK Investigational Site
Reiger Park, 1459
South AfricaActive - Recruiting
GSK Investigational Site
Westdene, 2092
South AfricaSite Not Available
GSK Investigational Site
Barcelona, 08036
SpainActive - Recruiting
GSK Investigational Site
Cordoba, 14004
SpainActive - Recruiting
GSK Investigational Site
Madrid, 28032
SpainActive - Recruiting
GSK Investigational Site
Banchiau Taipei, 220
TaiwanActive - Recruiting
GSK Investigational Site
Kaohsiung, 813
TaiwanActive - Recruiting
GSK Investigational Site
Bristol Avon, BS10 5NB
United KingdomActive - Recruiting
GSK Investigational Site
London, SE5 9RS
United KingdomActive - Recruiting
GSK Investigational Site
Bakersfield, California 93301
United StatesCompleted
GSK Investigational Site
San Francisco, California 94115
United StatesActive - Recruiting
GSK Investigational Site
Fort Pierce, Florida 33401
United StatesSite Not Available
GSK Investigational Site
Orlando, Florida 32803
United StatesActive - Recruiting
GSK Investigational Site
West Palm Beach, Florida 33409
United StatesActive - Recruiting
GSK Investigational Site
Baltimore, Maryland 21287
United StatesActive - Recruiting
GSK Investigational Site
Minneapolis, Minnesota 55415
United StatesActive - Recruiting
GSK Investigational Site
Hillsborough, New Jersey 08844
United StatesActive - Recruiting
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