Bepirovirsen for HIV and Hepatitis B (B-Focus Trial)

Phase 2

Recruiting

Research Sponsored by GlaxoSmithKline

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

History of or suspected liver cirrhosis and/or evidence of cirrhosis Diagnosed or suspected Hepatocellular carcinoma (HCC)

Coinfection with Hepatitis D virus (HDV) defined as positive or equivocal HDV antibody regardless of HDV RNA level

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at study week 60

Summary

"This trial will test whether bepirovirsen is effective and safe for people with both HIV and Hepatitis B compared to a placebo."

Who is the study for?

This trial is for people who have both HIV and chronic Hepatitis B. Specific details about eligibility criteria are not provided, but typically participants must meet certain health standards and may be required to follow specific protocols related to their conditions.

What is being tested?

The study is testing the effectiveness and safety of a medication called bepirovirsen compared to a placebo in individuals with both HIV and chronic Hepatitis B virus infection.

What are the potential side effects?

While the side effects of bepirovirsen are not detailed here, common side effects for antiviral drugs can include headaches, nausea, fatigue, and sometimes more serious reactions depending on individual health factors.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have or might have liver cirrhosis or liver cancer.

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I have or might have Hepatitis D.

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I am not on any immunosuppressive treatments, including high-dose steroids.

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I do not have major health issues aside from HIV or chronic HBV.

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I have or had vasculitis or an autoimmune disease like lupus or rheumatoid arthritis.

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I have been treated with bepirovirsen before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at study week 60

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at study week 60

This trial's timeline: 3 weeks for screening, Varies for treatment, and at study week 60 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of participants achieving hepatitis B virus (HBV) virologic response at 36 weeks after scheduled end of study treatment in absence of rescue medication

Secondary study objectives

Percentage of participants achieving HBV virologic response at the scheduled end of study treatment in absence of rescue medication