RecruitingNCT06264583

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

Euro-HDV:Epidemiology and Clinical Course in Patients With HIV and Hepatitis B/D -Coinfection

Sponsor

University Hospital, Bonn

Enrollment

8,000 participants

Start Date

May 1, 2024

Study Type

OBSERVATIONAL

Conditions

Hepatitis D

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how common hepatitis D virus (HDV) infection is among people who are living with both HIV and hepatitis B, and how HDV affects long-term health outcomes in this group. **You may be eligible if...** - You are 18 or older - You have a confirmed HIV infection - You have chronic hepatitis B (confirmed by two positive tests more than 6 months apart) **You may NOT be eligible if...** - You previously had hepatitis B but have since cleared it (you only have antibodies, not active infection) - You are under 18 - You are unable or unwilling to understand and cooperate with the study - In France: you do not have adequate health insurance coverage Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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