HIV InfectionsEuro-BNCT04984772
Prospective Cohort of HIV/HBV-coinfected Patients in Europe
An observational study of HIV Infections and Hepatitis B, run by Insel Gruppe AG, University Hospital Bern.
Trial summary
The overall aim of the project is to establish an international multi-cohort research platform of HIV/HBV-coinfected individuals treated with tenofovir to improve our understanding of the determinants of treatment outcomes. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- HIV Infections, Hepatitis B, Coinfection
- How many people
- 1,107 participants
- Where
- No sites listed yet
- Study dates
- 2 Oct 2001to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: HIV/HBV-coinfected individuals treated with tenofovir from Europe
Who may be able to join
- Study participant from contributing cohort
- 2 positive HBsAg tests more than 6 months apart
- At least 2 data points (baseline and 2 years after TDF/TAF start either as available data or stored sample
Who cannot join
- None
About this study
Official title: Understanding Treatment Outcomes of HIV/HBV Coinfection: A Prospective Cohort of HIV/HBV-coinfected Patients in Europe
The overall aim of the project is to establish an international multi-cohort research platform of HIV/HBV-coinfected individuals treated with tenofovir to improve our understanding of the determinants of treatment outcomes.
Read the detailed description
Hepatitis B virus (HBV) infection is a major cause of morbidity and mortality among human immunodeficiency virus (HIV)-infected individuals and the progression of liver disease is accelerated in this population compared to HBV-monoinfected individuals. Tenofovir disoproxil fumarate (TDF) or tenofovir alafenamide (TAF) as part of antiretroviral therapy (ART) suppresses HBV viral load in most patients. However, risk factors of suboptimal virological response to TDF/TAF and predictors of hepatitis B surface antigen (HBsAg) loss remain unclear. While novel drugs for HBV therapy are being developed, a more thorough understanding of the factors associated with optimal outcomes is urgent. Euro-B considers all HIV/HBV-coinfected participants from EuroSIDA, the Swiss HIV cohort study and French, Spanish and German HIV-HBV cohorts treated with TDF/TAF for inclusion.
The overall aim of the project is to establish an international prospective multi-cohort research platform of HIV/HBV-coinfected individuals to improve our understanding of the determinants of treatment outcomes, including functional cure of HBV infection. Specifically, we aim to:
- evaluate HBV virological suppression, hepatitis B e antigen (HBeAg) and HBsAg loss as well as the course of quantitative HBsAg (qHBsAg) levels during TDF/TAF-containing antiretroviral therapy
- evaluate predictors of HBsAg loss and its correlation with Hepatitis B core-related antigen (HBcrAg) and pre-genomic RNA (pgRNA) levels
- explore risk factors for low-level HBV replication after 2 years of therapy
- describe changes in liver fibrosis stage and rates of transaminase normalization over time and according to HBV therapy outcome
- assess rates and reasons of treatment interruptions or changes.
- Conditions
- HIV Infections, Hepatitis B, Coinfection
- Medical subject headings
- HIV Infections, Hepatitis B, Coinfection
What is being measured
The primary outcome is the main question the study is designed to answer.
HBV suppression
Proportion of participants achieving undetectable HBV DNA
Measured: 2 years of TDF/TAF-containing treatment and last available timepoint
HBsAg loss
Proportion of participants with a negative HBsAg measurement
Measured: 2 years of TDF/TAF-containing treatment and last available timepoint
HBeAg loss
Proportion of participants with a negative HBeAg measurement
Measured: 2 years of TDF/TAF-containing treatment and last available timepoint
Transaminase normalization
Proportion of participants with transaminase normalization
Measured: 2 years of TDF/TAF-containing treatment and last available timepoint
Liver fibrosis change
Proportion of participants with a change in liver fibrosis stage
Measured: 2 years of TDF/TAF-containing treatment and last available timepoint
Treatment interruption or change
Assessments of rates and reasons for treatment interruptions or changes
Measured: 2 years of TDF/TAF-containing treatment and last available timepoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start2 Oct 2001
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,107 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles Wandeler, MD MSc, Study chair, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04984772
- Sponsor's protocol ID
- Euro-B
- Other IDs
- CO-SW-985-5602
- Acronym
- Euro-B
- Status last verified
- Nov 2023
- First submitted
- 30 Jun 2021
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Begre L, Boyd A, Plissonnier ML, Testoni B, Beguelin C, Suter-Riniker F, Scholtes C, Rockstroh JK, Lacombe K, Peters L, Heil M, Levrero M, Rauch A, Zoulim F, Wandeler G; Swiss HIV Cohort Study, EuroSIDA and French HIV/HBV and Biliver cohorts; Members of the EuroSIDA Study Group; Members of the French HIV/HBV and Biliver cohorts. Circulating HBV RNA and hepatitis B core-related antigen as determinants of HBsAg loss in persons with HIV in Europe. JHEP Rep. 2025 Nov 7;8(2):101671. doi: 10.1016/j.jhepr.2025.101671. eCollection 2026 Feb.
PubMed 41551412
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Treatment Outcomes of HIV/HBV Coinfection: A Prospective Cohort of HIV/HBV-coinfected Patients in Europe
- ClinicalTrials.gov ID
- NCT04984772
- Acronym / sponsor ID
- Euro-B / Euro-B
- Conditions
- HIV Infections, Hepatitis B, Coinfection
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,107 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 2 Oct 2001 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 2 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall aim of the project is to establish an international multi-cohort research platform of HIV/HBV-coinfected individuals treated with tenofovir to improve our understanding of the determinants of treatment outcomes.
Detailed description
Hepatitis B virus (HBV) infection is a major cause of morbidity and mortality among human immunodeficiency virus (HIV)-infected individuals and the progression of liver disease is accelerated in this population compared to HBV-monoinfected individuals. Tenofovir disoproxil fumarate (TDF) or tenofovir alafenamide (TAF) as part of antiretroviral therapy (ART) suppresses HBV viral load in most patients. However, risk factors of suboptimal virological response to TDF/TAF and predictors of hepatitis B surface antigen (HBsAg) loss remain unclear. While novel drugs for HBV therapy are being developed, a more thorough understanding of the factors associated with optimal outcomes is urgent. Euro-B considers all HIV/HBV-coinfected participants from EuroSIDA, the Swiss HIV cohort study and French, Spanish and German HIV-HBV cohorts treated with TDF/TAF for inclusion.
The overall aim of the project is to establish an international prospective multi-cohort research platform of HIV/HBV-coinfected individuals to improve our understanding of the determinants of treatment outcomes, including functional cure of HBV infection. Specifically, we aim to:
- evaluate HBV virological suppression, hepatitis B e antigen (HBeAg) and HBsAg loss as well as the course of quantitative HBsAg (qHBsAg) levels during TDF/TAF-containing antiretroviral therapy
- evaluate predictors of HBsAg loss and its correlation with Hepatitis B core-related antigen (HBcrAg) and pre-genomic RNA (pgRNA) levels
- explore risk factors for low-level HBV replication after 2 years of therapy
- describe changes in liver fibrosis stage and rates of transaminase normalization over time and according to HBV therapy outcome
- assess rates and reasons of treatment interruptions or changes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- HIV/HBV-coinfected individuals treated with tenofovir from Europe
Key inclusion criteria (3 listed)
- Study participant from contributing cohort
- 2 positive HBsAg tests more than 6 months apart
- At least 2 data points (baseline and 2 years after TDF/TAF start either as available data or stored sample
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HBV suppression
Time frame: 2 years of TDF/TAF-containing treatment and last available timepoint
Proportion of participants achieving undetectable HBV DNA
HBsAg loss
Time frame: 2 years of TDF/TAF-containing treatment and last available timepoint
Proportion of participants with a negative HBsAg measurement
HBeAg loss
Time frame: 2 years of TDF/TAF-containing treatment and last available timepoint
Proportion of participants with a negative HBeAg measurement
Transaminase normalization
Time frame: 2 years of TDF/TAF-containing treatment and last available timepoint
Proportion of participants with transaminase normalization
Liver fibrosis change
Time frame: 2 years of TDF/TAF-containing treatment and last available timepoint
Proportion of participants with a change in liver fibrosis stage
Treatment interruption or change
Time frame: 2 years of TDF/TAF-containing treatment and last available timepoint
Assessments of rates and reasons for treatment interruptions or changes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Derived from this study: PubMed 41551412Begre L, Boyd A, Plissonnier ML, Testoni B, Beguelin C, Suter-Riniker F, Scholtes C, Rockstroh JK, Lacombe K, Peters L, Heil M, Levrero M, Rauch A, Zoulim F, Wandeler G; Swiss HIV Cohort Study, EuroSIDA and French HIV/HBV and Biliver cohorts; Members of the EuroSIDA Study Group; Members of the French HIV/HBV and Biliver cohorts. Circulating HBV RNA and hepatitis B core-related antigen as determinants of HBsAg loss in persons with HIV in Europe. JHEP Rep. 2025 Nov 7;8(2):101671. doi: 10.1016/j.jhepr.2025.101671. eCollection 2026 Feb.
- Individual participant dataSharing planned: Undecided
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gilles Wandeler, MD MSc study chair
Insel Gruppe AG, University Hospital Bern
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Hepatitis B, run by Insel Gruppe AG, University Hospital Bern.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HBV suppression (time frame: 2 years of TDF/TAF-containing treatment and last available timepoint). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04984772, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.