Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepati… (NCT06497504) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
United States157 participantsStarted 2024-09-17
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Documented chronic hepatitis B virus (HBV) infection and documented human immunodeficiency virus (HIV)-1 infection greater than equal to (\>=) 12 months prior to Screening.
✓. 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.
✓. 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.
✓. 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).
✓. 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 \<50 copies/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 criteria
✕. History of or suspected liver cirrhosis and/or evidence of cirrhosis.
✕. Diagnosed or suspected hepatocellular carcinoma (HCC).
What they're measuring
1
Percentage of participants achieving hepatitis B virus (HBV) virologic response at 36 weeks after scheduled end of study treatment in absence of rescue medication
✕. 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 at Screening.
✕. Hepatitis D virus (HDV) defined as positive or equivocal HDV antibody regardless of HDV RNA level.
✕. 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.
✕. 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.