Phase
Condition
Hepatitis
Hiv Infections
Hepatitis B
Treatment
Bepirovirsen
Placebo
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
ArgentinaSite Not Available
GSK Investigational Site
Almagro 3436397, C1427CEA
ArgentinaSite Not Available
GSK Investigational Site
Buenos Aires, 1023
ArgentinaSite Not Available
GSK Investigational Site
Buenos Aires 3435910, C1425AGC
ArgentinaSite Not Available
GSK Investigational Site
La Plata, B1900AVG
ArgentinaSite Not Available
GSK Investigational Site
La Plata 3432043, B1900AVG
ArgentinaSite Not Available
GSK Investigational Site
Rosario, S2002KDR
ArgentinaSite Not Available
GSK Investigational Site
Rosario 3838583, S2002KDR
ArgentinaSite Not Available
GSK Investigational Site
Aracaju, 49060-010
BrazilSite Not Available
GSK Investigational Site
Aracaju 3471872, 49060-010
BrazilSite Not Available
GSK Investigational Site
Campinas, 13034-685
BrazilSite Not Available
GSK Investigational Site
Campinas 3467865, 13034-685
BrazilSite Not Available
GSK Investigational Site
Curitiba, 80810-050
BrazilSite Not Available
GSK Investigational Site
Curitiba 3464975, 80810-050
BrazilSite Not Available
GSK Investigational Site
Manaus, 69040-000
BrazilSite Not Available
GSK Investigational Site
Manaus 3663517, 69040-000
BrazilSite Not Available
GSK Investigational Site
SAo Paulo, 04121-000
BrazilSite Not Available
GSK Investigational Site
Salvador, 40110-060
BrazilSite Not Available
GSK Investigational Site
Salvador 3450554, 40110-060
BrazilSite Not Available
GSK Investigational Site
São Paulo, 04121-000
BrazilSite Not Available
GSK Investigational Site
São Paulo 3448439, 04121-000
BrazilSite Not Available
GSK Investigational Site
Ottawa, Ontario K1H 8L6
CanadaSite Not Available
GSK Investigational Site
Toronto, Ontario M5G 1K2
CanadaSite Not Available
GSK Investigational Site
Ottawa 6094817, Ontario 6093943 K1H 8L6
CanadaSite Not Available
GSK Investigational Site
Toronto 6167865, Ontario 6093943 M5G 1K2
CanadaSite Not Available
GSK Investigational Site
Montreal, Quebec H2L 4P9
CanadaSite Not Available
GSK Investigational Site
Quebec City, Quebec G1V 4G2
CanadaSite Not Available
GSK Investigational Site
Québec, Quebec G1V 4G2
CanadaSite Not Available
GSK Investigational Site
Montreal 6077243, Quebec 6115047 H4A 3J1
CanadaSite Not Available
GSK Investigational Site
Québec 6325494, Quebec 6115047 G1V 4G2
CanadaSite Not Available
GSK Investigational Site
Marseille, 13003
FranceSite Not Available
GSK Investigational Site
Marseille 2995469, 13003
FranceSite Not Available
GSK Investigational Site
Melun, 77000
FranceSite Not Available
GSK Investigational Site
Melun 2994651, 77000
FranceSite Not Available
GSK Investigational Site
Montpellier, 34295
FranceSite Not Available
GSK Investigational Site
Montpellier 2992166, 34295
FranceSite Not Available
GSK Investigational Site
Montpellier Cedex 5, 34295
FranceSite Not Available
GSK Investigational Site
Nantes, 44093
FranceSite Not Available
GSK Investigational Site
Nantes 2990969, 44093
FranceSite Not Available
GSK Investigational Site
Nantes cedex 1, 44093
FranceSite Not Available
GSK Investigational Site
Paris, 75012
FranceSite Not Available
GSK Investigational Site
Paris 2988507, 75012
FranceSite Not Available
GSK Investigational Site
Firenze, 50134
ItalySite Not Available
GSK Investigational Site
Genova, 16132
ItalySite Not Available
GSK Investigational Site
Genova 8969657, 16132
ItalySite Not Available
GSK Investigational Site
Milan, 20162
ItalySite Not Available
GSK Investigational Site
Milan 6951411, 20157
ItalySite Not Available
GSK Investigational Site
Milano, 20157
ItalySite Not Available
GSK Investigational Site
Naples, 80131
ItalySite Not Available
GSK Investigational Site
Napoli, 80131
ItalySite Not Available
GSK Investigational Site
Napoli 9031661, 80131
ItalySite Not Available
GSK Investigational Site
Roma, 00153
ItalySite Not Available
GSK Investigational Site
Roma 8957247, 00153
ItalySite Not Available
GSK Investigational Site
Sassari, 07100
ItalySite Not Available
GSK Investigational Site
Sassari 3167096, 07100
ItalySite Not Available
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 AfricaSite Not Available
GSK Investigational Site
Durban 1007311, 4052
South AfricaSite Not Available
GSK Investigational Site
Johannesburg, 2092
South AfricaSite Not Available
GSK Investigational Site
Johannesburg 993800, 2092
South AfricaSite Not Available
GSK Investigational Site
Observatory, Cape Town, 7925
South AfricaSite Not Available
GSK Investigational Site
Reiger Park, 1459
South AfricaSite Not Available
GSK Investigational Site
Reiger Park 11203904, 1459
South AfricaSite Not Available
GSK Investigational Site
Westdene, 2092
South AfricaSite Not Available
GSK Investigational Site
Barcelona, 08036
SpainSite Not Available
GSK Investigational Site
Barcelona 3128760, 08036
SpainSite Not Available
GSK Investigational Site
Cordoba, 14004
SpainSite Not Available
GSK Investigational Site
Córdoba, 14004
SpainSite Not Available
GSK Investigational Site
Córdoba 2519240, 14004
SpainSite Not Available
GSK Investigational Site
Madrid, 28040
SpainSite Not Available
GSK Investigational Site
Madrid 3117735, 28032
SpainSite Not Available
GSK Investigational Site
Banchiau Taipei, 220
TaiwanSite Not Available
GSK Investigational Site
Kaohsiung, 813
TaiwanSite Not Available
GSK Investigational Site
Kaohsiung City, 813
TaiwanSite Not Available
GSK Investigational Site
Kaohsiung City 1673820, 813
TaiwanSite Not Available
GSK Investigational Site
Bristol Avon, BS10 5NB
United KingdomSite Not Available
GSK Investigational Site
London, E1 1BB
United KingdomSite Not Available
GSK Investigational Site
London 2643743, NW3 2QG
United KingdomSite Not Available
GSK Investigational Site
Bakersfield, California 93301
United StatesSite Not Available
GSK Investigational Site
San Francisco, California 94115
United StatesSite Not Available
GSK Investigational Site
Bakersfield 5325738, California 5332921 93301
United StatesSite Not Available
GSK Investigational Site
San Francisco 5391959, California 5332921 94115
United StatesSite Not Available
GSK Investigational Site
Fort Pierce, Florida 33401
United StatesSite Not Available
GSK Investigational Site
Orlando, Florida 32803
United StatesSite Not Available
GSK Investigational Site
West Palm Beach, Florida 33409
United StatesSite Not Available
GSK Investigational Site
Orlando 4167147, Florida 4155751 32803
United StatesSite Not Available
GSK Investigational Site
West Palm Beach 4177887, Florida 4155751 33409
United StatesSite Not Available
GSK Investigational Site
Baltimore, Maryland 21287
United StatesSite Not Available
GSK Investigational Site
Baltimore 4347778, Maryland 4361885 21287
United StatesSite Not Available
GSK Investigational Site
Minneapolis, Minnesota 55415
United StatesSite Not Available
GSK Investigational Site
Minneapolis 5037649, Minnesota 5037779 55415
United StatesSite Not Available
GSK Investigational Site
Hillsborough, New Jersey 08844
United StatesSite Not Available
GSK Investigational Site
Hillsborough 5099079, New Jersey 5101760 08844
United StatesSite Not Available

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