NCT04984772

Brief 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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,107

participants targeted

Target at P75+ for all trials

Timeline
55mo left

Started Oct 2001

Longer than P75 for all trials

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Oct 2001Dec 2030

Study Start

First participant enrolled

October 2, 2001

Completed
19.8 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 2, 2021

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

December 1, 2023

Status Verified

November 1, 2023

Enrollment Period

29.3 years

First QC Date

June 30, 2021

Last Update Submit

November 30, 2023

Conditions

Outcome Measures

Primary Outcomes (6)

  • HBV suppression

    Proportion of participants achieving undetectable HBV DNA

    2 years of TDF/TAF-containing treatment and last available timepoint

  • HBsAg loss

    Proportion of participants with a negative HBsAg measurement

    2 years of TDF/TAF-containing treatment and last available timepoint

  • HBeAg loss

    Proportion of participants with a negative HBeAg measurement

    2 years of TDF/TAF-containing treatment and last available timepoint

  • Transaminase normalization

    Proportion of participants with transaminase normalization

    2 years of TDF/TAF-containing treatment and last available timepoint

  • Liver fibrosis change

    Proportion of participants with a change in liver fibrosis stage

    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

    2 years of TDF/TAF-containing treatment and last available timepoint

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HIV/HBV-coinfected individuals treated with tenofovir from Europe

You may qualify if:

  • Study participant from contributing cohort
  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma/serum

MeSH Terms

Conditions

HIV InfectionsHepatitis BCoinfection

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHepadnaviridae InfectionsDNA Virus InfectionsHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Gilles Wandeler, MD MSc

    Insel Gruppe AG, University Hospital Bern

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2021

First Posted

August 2, 2021

Study Start

October 2, 2001

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

December 1, 2023

Record last verified: 2023-11