Descriptive Analysis of Changes in Hepatitis B Markers in... | NCT06421259

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

NCT06421259

Sponsor

Centre Hospitalier Universitaire de Nice

Status

Unknown status

Last Update Posted

May 20, 2024Actual

Enrollment

15Estimated

Phase

Not provided

Conditions

Hiv Infection
Hepatitis B

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 20, 2024Estimated

Primary Completion Date

May 20, 2026Estimated

Completion Date

May 20, 2026Estimated

First Submitted Date

May 13, 2024

First Submission Date that Met QC Criteria

May 15, 2024

First Posted Date

May 20, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 15, 2024

Last Update Posted Date

May 20, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HIV infected patients under injectable ART		HIV infected patients under injectable ART

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

-HIV infected patients under injectable ART

Exclusion Criteria:

-Active HBV infection

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alissa NAQVI	Contact	492035468	+33	naqvi.a@chu-nice.fr

Overall Officials

Name	Affiliation	Role
Alissa NAQVI	Centre Hospitalier Universitaire de Nice	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU NiICE		Nice	Alpes Maritimes	0600	France

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections
D006509	Hepatitis B

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

Browse Leaves

Not provided

Browse Branches

Not provided