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

Part of paid clinical trials in Bakersfield, California.

Sponsor
GlaxoSmithKline
Study ID
NCT06497504
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bepirovirsen — DRUG
    Bepirovirsen will be administered.
  • Placebo — DRUG
    Placebo will be administered.

Study Details

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.

Key Dates

Start date
Sep 17, 2024
Status verified
May 2026
Primary completion
Apr 22, 2027
Completion
Apr 22, 2027

Study Design

Enrollment
153 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Participants receiving Bepirovirsen
    Participants will receive bepirovirsen.
  • Placebo Comparator: Participants receiving Placebo
    Participants will receive placebo.

Primary Outcome Measure

Percentage of participants achieving hepatitis B virus (HBV) virologic response at 36 weeks after scheduled end of study treatment in absence of rescue medication [ Time Frame: At study week 60 ]

Locations (7)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteBakersfieldCalifornia93301-
GSK Investigational SiteSan FranciscoCalifornia94115-
GSK Investigational SiteOrlandoFlorida32803-
GSK Investigational SiteWest Palm BeachFlorida33409-
GSK Investigational SiteBaltimoreMaryland21287-
GSK Investigational SiteMinneapolisMinnesota55415-
GSK Investigational SiteHillsboroughNew Jersey08844-

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