HDV-Europe: Prevalence and Outcome of HDV in HIV/HBV Coinfection (NCT06264583) | Clinical Trial Compass
UnknownNot Applicable
HDV-Europe: Prevalence and Outcome of HDV in HIV/HBV Coinfection
Germany8,000 participantsStarted 2024-05-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.