Assessing Hepatitis D prevalence in HIV and HBV coinfected patients in Europe
Euro-HDV:Epidemiology and Clinical Course in Patients With HIV and Hepatitis B/D -Coinfection
This study is trying to find out how common Hepatitis D is in people who have both HIV and Hepatitis B in Europe, while also looking at how well current testing guidelines are being followed.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 8000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bonn Academic / other |
| Locations | 1 site (Bonn, North Rhine-Westphalia) |
| Trial ID | NCT06264583 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the prevalence of Hepatitis D virus (HDV) among individuals living with HIV and chronic Hepatitis B virus (HBV) infection across several European countries. It will assess the implementation of EACS guidelines for HDV testing and analyze existing data to determine the rates of HDV infection and associated risk factors. Additionally, a cohort and database will be established for future studies on HDV among this population, incorporating clinical, virological, and laboratory parameters.
Who should consider this trial
Good fit: Ideal candidates for this study are adults living with HIV who also have chronic HBV infection.
Not a fit: Patients who have cleared HBV infection or are under 18 years of age will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved screening and management of HDV in HIV/HBV coinfected patients, potentially reducing liver disease-related complications.
How similar studies have performed: Other studies have shown varying rates of HDV infection in similar populations, indicating that this approach is relevant and necessary for understanding HDV prevalence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Documented HIV-infection confirmed by HIV-ELISA * Chronic HBV Infection confirmed by d HBV HBsAg-testing (2 measurements of positive HBsAg \> 6month interval). Exclusion Criteria: * 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.
Where this trial is running
Bonn, North Rhine-Westphalia
- University Hospital Bonn — Bonn, North Rhine-Westphalia, Germany (Recruiting)
Study contacts
- Principal investigator: Jürgen Rockstroh, MD — University Hospital, Bonn
- Study coordinator: Jürgen Rockstroh
- Email: juergen.rockstroh@ukbonn.de
- Phone: +491716575969
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.