Descriptive Analysis of Changes in Hepatitis B Markers in People Living With HIV on Injectable Therapy.
To Switch or Not to Switch to CAB/RPV in PLWH With Past HBV Infection? Risk of HBV Reactivation? A Need for New HBV Markers?
1 other identifier
observational
15
1 country
1
Brief Summary
In order to assess the risk of hepatitis B reactivation in people living with HIV and undergoing injection therapy, we propose to carry out a descriptive analysis of the evolution of hepatitis B markers in this population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2024
CompletedFirst Posted
Study publicly available on registry
May 20, 2024
CompletedStudy Start
First participant enrolled
May 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2026
CompletedMay 20, 2024
March 1, 2024
2 years
May 13, 2024
May 15, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Risk of HBV reactivation under injectable HIV ART
HBV serology, DNA HBV levels
From start of injectable HIV treatment to hepatitis B reactivation, assessed up to 24 months
Study Arms (1)
HIV infected patients under injectable ART
HIV infected patients under injectable ART
Eligibility Criteria
HIV infected patients attending care in the infectiious disease department of the Universitary Hospital of Nice
You may qualify if:
- HIV infected patients under injectable ART
You may not qualify if:
- Active HBV infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU NiICE
Nice, Alpes Maritimes, 0600, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alissa NAQVI
Centre Hospitalier Universitaire de Nice
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2024
First Posted
May 20, 2024
Study Start
May 20, 2024
Primary Completion
May 20, 2026
Study Completion
May 20, 2026
Last Updated
May 20, 2024
Record last verified: 2024-03