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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Documented HIV-infection confirmed by HIV-ELISA

• Chronic HBV Infection confirmed by d HBV HBsAg-testing (2 measurements of positive HBsAg \> 6month interval).

Locations
Other Locations
Germany
University Hospital Bonn
RECRUITING
Bonn
Contact Information
Primary
Jürgen Rockstroh
juergen.rockstroh@ukbonn.de
+491716575969
Time Frame
Start Date: 2024-05-01
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 8000
Related Therapeutic Areas
Sponsors
Collaborators: Royal Free Hospital NHS Foundation Trust, ICONA Cohort, Hospital Universitario Infanta Leonor, GEPCOI (Portuguese Group of Coinfection), University Hospital of Cologne, University Hospital, Essen, Amsterdam UMC, Sorbonne University, Swiss HIV Cohort Study, Goethe University, Henri Mondor University Hospital, Hospital General Universitario Gregorio Marañon, Heinrich-Heine University, Duesseldorf, ICH Hamburg, Praxiszentrum Hohenstaufenring Köln, King's College London
Leads: University Hospital, Bonn

This content was sourced from clinicaltrials.gov