Descriptive Analysis of Changes in Hepatitis B Markers in People Living With HIV on Injectable Therapy.

May 15, 2024 updated by: Centre Hospitalier Universitaire de Nice

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?

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Alpes Maritimes
      • Nice, Alpes Maritimes, France, 0600

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

HIV infected patients attending care in the infectiious disease department of the Universitary Hospital of Nice

Description

Inclusion Criteria:

-HIV infected patients under injectable ART

Exclusion Criteria:

-Active HBV infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
HIV infected patients under injectable ART

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk of HBV reactivation under injectable HIV ART
Time Frame: From start of injectable HIV treatment to hepatitis B reactivation, assessed up to 24 months
HBV serology, DNA HBV levels
From start of injectable HIV treatment to hepatitis B reactivation, assessed up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: Alissa NAQVI, Centre Hospitalier Universitaire De Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 20, 2024

Primary Completion (Estimated)

May 20, 2026

Study Completion (Estimated)

May 20, 2026

Study Registration Dates

First Submitted

May 13, 2024

First Submitted That Met QC Criteria

May 15, 2024

First Posted (Actual)

May 20, 2024

Study Record Updates

Last Update Posted (Actual)

May 20, 2024

Last Update Submitted That Met QC Criteria

May 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24Infectio01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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