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

NCT06264583 | Recruiting

• 1 other identifier: IN-DE-980-6998
• Study Type: observational
• Target: 8,000
• Locations: 1 country
• Sites: 1

Brief 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. 1.Analyze the rate of HDV-testing and evaluate the prevalence of HDV-infection by testing.
2. 2.Evaluation of former screening of HDV by assessing existing data at study sites.
3. 3.Determination of the HDV prevalence in European PLWH and HBV coinfection.
4. 4.Setting up a database of all PLWH with HBV/HDV coinfection
5. 5.Analysis of transmission risk factors for HDV coinfection
6. 6.Asses the rate of HDV positive patients with ongoing HDV replication.
7. 7.Define the liver disease state by APRI score, fibroscan, ultrasound and routine laboratory test results.

Conditions

Hepatitis D

Keywords

HIV; hepatitis B; hepatitis delta; liver disease associated death

Outcome Measures

Primary Outcomes (1)

• HDV prevalence in HIV/HBV coinfection

  percentage of HDV seropositive individuls with HIV/HBV coinfection

  all data collected in 2023

Secondary Outcomes (1)

• Degree of liver disease in pateints with HIV/HBV/HDV triple infection

  all data collected in 2023

Interventions

HDV screening OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

To secure representative data, each cohort or clinic network will aim to enroll a sample size of at least 20% of all HIV/HBV-coinfected individuals in each country. The overall number of participants is planned to reach at least 8000 HIV/HBV-coinfected persons. With an estimated 800.000 PLWH in the following 9 countries: Spain 150.00, France 190.000, Germany 93.000, England 106.000, Portugal 61.000, Italy 140.000, Poland 20.000, Switzerland 16.000, Netherlands 24.000, and an estimated HBV-Prevalence of 5%, this would lead to a cohort of around 40.000 HIV/HBV coinfected individuals. According to current data, 20% of HIV/HBV-coinfected PLWH are expected to have an HDV-infection, which should add up to 8000 individuals that would be needed to be studied.

You may qualify if:

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

You may not qualify if:

• PLWH with a cleared HBV-infection (anti-HBc or anti-HBc and anti-HBs antibody positive will be considered as HIV-monoinfected persons.
• Individuals younger than 18 years of age
• Patients with any social condition or living circumstances which may interfere with the conduct of the study, as anticipated by the investigator, such as incapacity to adequately understand the study content or not willing to cooperate will be excluded from the study. -For France, patients without adequate social security will be excluded.

Sponsors & Collaborators

• University Hospital, Bonn: lead
• Swiss HIV Cohort Study: collaborator
• ICONA Cohort: collaborator
• Amsterdam UMC: collaborator
• Royal Free Hospital NHS Foundation Trust: collaborator
• King's College London: collaborator
• University Hospital of Cologne: collaborator
• Goethe University: collaborator
• Heinrich-Heine University, Duesseldorf: collaborator
• University Hospital, Essen: collaborator
• ICH Hamburg: collaborator
• Praxiszentrum Hohenstaufenring Köln: collaborator
• Sorbonne University: collaborator
• Henri Mondor University Hospital: collaborator
• Hospital Universitario Infanta Leonor: collaborator
• Hospital General Universitario Gregorio Marañon: collaborator
• GEPCOI (Portuguese Group of Coinfection): collaborator

Study Sites (1)

University Hospital Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

RECRUITING

Related Publications (1)

• Botelho-Souza LF, Vasconcelos MPA, Dos Santos AO, Salcedo JMV, Vieira DS. Hepatitis delta: virological and clinical aspects. Virol J. 2017 Sep 13;14(1):177. doi: 10.1186/s12985-017-0845-y.

  PMID: 28903779 BACKGROUND

MeSH Terms

Conditions

Hepatitis D; Hepatitis B

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Human; Virus Diseases; Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections

Study Officials

• Jürgen Rockstroh, MD

  University Hospital, Bonn

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jürgen Rockstroh

CONTACT

+491716575969; juergen.rockstroh@ukbonn.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Infectious Diseases

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 20, 2024
• Study Start: May 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)