RECRUITING

Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)

Conditions

Hepatitis B Antiretroviral treatment Bepirovirsen Human immunodeficiency virus Hepatitis B virus Placebo

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will evaluate the efficacy and safety of bepirovirsen compared to placebo in participants with human immunodeficiency virus (HIV)/hepatitis B virus (HBV) co-infection.

Official Title

A Multicenter, Randomized, Double-Blind, Placebo-controlled Study to Assess the Efficacy and Safety of Treatment With Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection on Antiretroviral Treatment

Quick Facts

Study Start:2024-09-17

Study Completion:2027-05-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06497504

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. 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).	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. 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.

Inclusion Criteria

Exclusion 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.
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).

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.
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.

Contacts and Locations

Study Contact

US GSK Clinical Trials Call Center

CONTACT

877-379-3718

GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466

GSKClinicalSupportHD@gsk.com

Principal Investigator

GSK Clinical Trials

STUDY_DIRECTOR

GlaxoSmithKline

Study Locations (Sites)

GSK Investigational Site

Bakersfield, California, 93301

United States

GSK Investigational Site

Fort Pierce, Florida, 33401

United States

GSK Investigational Site

Orlando, Florida, 32803

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

Collaborators and Investigators

Sponsor: GlaxoSmithKline

GSK Clinical Trials, STUDY_DIRECTOR, GlaxoSmithKline

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-17

Study Completion Date2027-05-03

Study Record Updates

Study Start Date2024-09-17

Study Completion Date2027-05-03

Terms related to this study

Keywords Provided by Researchers

Antiretroviral treatment
Bepirovirsen
Human immunodeficiency virus
Hepatitis B virus
Placebo

Additional Relevant MeSH Terms

Hepatitis B