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

Status: Recruiting
Location: See all (52) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• 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 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).

Locations
United States
California
GSK Investigational Site
COMPLETED
Bakersfield
GSK Investigational Site
RECRUITING
San Francisco
Florida
GSK Investigational Site
RECRUITING
Orlando
GSK Investigational Site
RECRUITING
West Palm Beach
Maryland
GSK Investigational Site
RECRUITING
Baltimore
Minnesota
GSK Investigational Site
RECRUITING
Minneapolis
New Jersey
GSK Investigational Site
RECRUITING
Hillsborough
Other Locations
Argentina
GSK Investigational Site
RECRUITING
Almagro
GSK Investigational Site
RECRUITING
Buenos Aires
GSK Investigational Site
RECRUITING
Buenos Aires
GSK Investigational Site
RECRUITING
Buenos Aires
GSK Investigational Site
RECRUITING
La Plata
GSK Investigational Site
RECRUITING
Rosario
Brazil
GSK Investigational Site
RECRUITING
Aracaju
GSK Investigational Site
RECRUITING
Campinas
GSK Investigational Site
RECRUITING
Curitiba
GSK Investigational Site
RECRUITING
Manaus
GSK Investigational Site
RECRUITING
Salvador
GSK Investigational Site
RECRUITING
São Paulo
Canada
GSK Investigational Site
RECRUITING
Montreal
GSK Investigational Site
RECRUITING
Montreal
GSK Investigational Site
RECRUITING
Ottawa
GSK Investigational Site
RECRUITING
Québec
GSK Investigational Site
RECRUITING
Toronto
France
GSK Investigational Site
RECRUITING
Marseille
GSK Investigational Site
RECRUITING
Melun
GSK Investigational Site
RECRUITING
Montpellier
GSK Investigational Site
RECRUITING
Nantes
GSK Investigational Site
RECRUITING
Paris
GSK Investigational Site
RECRUITING
Paris
Italy
GSK Investigational Site
RECRUITING
Florence
GSK Investigational Site
RECRUITING
Genova
GSK Investigational Site
RECRUITING
Milan
GSK Investigational Site
RECRUITING
Milan
GSK Investigational Site
RECRUITING
Napoli
GSK Investigational Site
RECRUITING
Roma
GSK Investigational Site
RECRUITING
Sassari
South Africa
GSK Investigational Site
RECRUITING
Durban
GSK Investigational Site
RECRUITING
Johannesburg
GSK Investigational Site
RECRUITING
Reiger Park
Spain
GSK Investigational Site
RECRUITING
Barcelona
GSK Investigational Site
RECRUITING
Córdoba
GSK Investigational Site
RECRUITING
Madrid
GSK Investigational Site
RECRUITING
Madrid
GSK Investigational Site
RECRUITING
Madrid
GSK Investigational Site
RECRUITING
Madrid
Taiwan
GSK Investigational Site
RECRUITING
Banchiau Taipei
GSK Investigational Site
RECRUITING
Kaohsiung City
United Kingdom
GSK Investigational Site
RECRUITING
Bristol Avon
GSK Investigational Site
RECRUITING
London
GSK Investigational Site
RECRUITING
London
GSK Investigational Site
RECRUITING
London
Contact Information
Primary
US GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
877-379-3718
Backup
EU GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
+44 (0) 20 89904466
Time Frame
Start Date: 2024-09-17
Estimated Completion Date: 2027-04-27
Participants
Target number of participants: 150
Treatments
Experimental: Participants receiving Bepirovirsen
Participants will receive bepirovirsen.
Placebo_comparator: Participants receiving Placebo
Participants will receive placebo.
Related Therapeutic Areas
Sponsors
Leads: GlaxoSmithKline

This content was sourced from clinicaltrials.gov