BridgeMD
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
EU CTIS ID: 2023-509588-25-00
What this study is testing
To assess the treatment effect of 24 weeks bepirovirsen with loading doses to achieve a Hepatitis B Virus (HBV) virologic response 36 weeks off study treatment in participants with chronic Human Immunodeficiency Virus (HIV)/HBV coinfection on HBV and HIV active Antiretroviral treatment (ART) with Baseline HBV surface antigen (HBsAg) less than or equal to (<=)3000 International units (IU)/ milliLiter (mL).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Documented chronic HBV infection and documented HIV-1 infection greater than equal to (>=)12 months prior to screening
- Must be on uninterrupted 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)
- Documented evidence of at least 2 plasma HIV-1 Ribonucleic acid (RNA) measurements <50 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 DNA concentration must be adequately suppressed, defined as plasma or serum HBV DNA <90 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/Cubic Millimeters (mm3)
You likely can't join if
- History of or suspected liver cirrhosis and/or evidence of cirrhosis. Diagnosed or suspected Hepatocellular carcinoma (HCC)
- 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
- Participants to whom immunosuppressive treatment, including therapeutic doses of steroids, is contraindicated should not be considered for enrolment in the study
- Currently taking, or has taken within 12 months of Screening, any interferon containing therapy
- 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.
- Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of screening
See the full eligibility criteria
Who can join
- Documented chronic HBV infection and documented HIV-1 infection greater than equal to (>=)12 months prior to screening
- Must be on uninterrupted 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)
- Documented evidence of at least 2 plasma HIV-1 Ribonucleic acid (RNA) measurements <50 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 DNA concentration must be adequately suppressed, defined as plasma or serum HBV DNA <90 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/Cubic Millimeters (mm3)
- Alanine aminotransferase (ALT) <=2 times Upper limit of normal (ULN)
What rules you out
- History of or suspected liver cirrhosis and/or evidence of cirrhosis. Diagnosed or suspected Hepatocellular carcinoma (HCC)
- 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
- Participants to whom immunosuppressive treatment, including therapeutic doses of steroids, is contraindicated should not be considered for enrolment in the study
- Currently taking, or has taken within 12 months of Screening, any interferon containing therapy
- 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.
- 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
- 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: a. 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 b. 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
- 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
- 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)
- Participants who in the investigator’s judgment, have a significant risk of suicide or self-harm
- Alcohol or drug abuse/dependence
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Brazil
- Taiwan
- South Africa
- United States
- Argentina
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Brazil; Taiwan; South Africa; United States; Argentina and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.