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RECRUITING
NCT06264583

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

Sponsor: University Hospital, Bonn

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

8000

Start Date

2024-05-01

Completion Date

2025-06-30

Last Updated

2024-05-24

Healthy Volunteers

No

Conditions

Interventions

OTHER

HDV screening

1\. Analyze the rate of HDV-testing and evaluate the prevalence of HDV-infection by testing.

Locations (1)

University Hospital Bonn

Bonn, North Rhine-Westphalia, Germany