Actively Recruiting

Age: 18Years +
All Genders
NCT06264583

HDV-Europe: Prevalence and Outcome of HDV in HIV/HBV Coinfection

Led by University Hospital, Bonn · Updated on 2024-05-24

8000

Participants Needed

1

Research Sites

60 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Bonn

Lead Sponsor

S

Swiss HIV Cohort Study

Collaborating Sponsor

AI-Summary

What this Trial Is About

The aim of this project is to set up a cross-sectional cohort study (France, Germany, The Netherlands, Poland, Spain, Switzerland, Italy, United Kingdom and Portugal) to assess the implementation of EACS guidelines for HDV-testing among PLWH with positive HbsAg and thereby evaluate the prevalence of HDV infection among HIV/HBV-coinfected in 2023, as well as corresponding risk factors. In addition to the testing itself, this study will also set up a cohort and databasee for future HDV studies among PLWH, including clinical, virological und laboratory parameters. 1. Analyze the rate of HDV-testing and evaluate the prevalence of HDV-infection by testing. 1. Evaluation of former screening of HDV by assessing existing data at study sites. 2. Determination of the HDV prevalence in European PLWH and HBV coinfection. 2. Setting up a database of all PLWH with HBV/HDV coinfection 1. Analysis of transmission risk factors for HDV coinfection 2. Asses the rate of HDV positive patients with ongoing HDV replication. 3. Define the liver disease state by APRI score, fibroscan, ultrasound and routine laboratory test results.

CONDITIONS

Official Title

HDV-Europe: Prevalence and Outcome of HDV in HIV/HBV Coinfection

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Documented HIV infection confirmed by HIV-ELISA
  • Chronic Hepatitis B infection confirmed by two positive HBsAg tests taken more than 6 months apart
Not Eligible

You will not qualify if you...

  • People living with HIV who have cleared Hepatitis B infection (anti-HBc or anti-HBc and anti-HBs antibody positive)
  • Individuals younger than 18 years old
  • Patients with social or living conditions that may prevent proper study participation or understanding
  • In France, patients without adequate social security coverage

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University Hospital Bonn

Bonn, North Rhine-Westphalia, Germany, 53127

Actively Recruiting

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Research Team

J

Jürgen Rockstroh

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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