Hepatitis B Virus Vertical Transmission From HIV-HBV Co-i... | NCT02044068

Studies
Hepatitis B Virus Vertical Transmission From HIV-HBV Co-infected Women

NCT02044068

Sponsor

Hopital Lariboisière

Status

Completed

Last Update Posted

Apr 28, 2017Actual

Enrollment

35Actual

Phase

Not provided

Conditions

Vertical Disease Transmission
HBV

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

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Sep 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Jan 17, 2014

First Submission Date that Met QC Criteria

Jan 21, 2014

First Posted Date

Jan 23, 2014Estimated

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

Apr 26, 2017

Last Update Posted Date

Apr 28, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Célia Lloret-Linares, MD PhD, Professor at Paris VII Denis Diderot University, physician, Hopital LariboisièrePrincipal Investigator

Lead Sponsor

Hopital LariboisièreOTHER

Collaborators

Not provided

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

Vertical HIV transmission has been dramatically reduced by the use of combined antiretroviral therapy in HIV-infected pregnant women. Among the most often used drugs, several have dual activity, against HIV and HBV: lamivudine, emtricitabine, tenofovir. Studies about vertical HBV transmission from HIV-HBV co-infected pregnant women are rare in developed countries. The study hypothesis is a major reduction of the risk of HBV vertical transmission.

Detailed Description

Mother-to-Child HIV transmission has been dramatically reduced by the use of combined antiretroviral therapy in HIV-infected pregnant women, both in developed and in developing countries. Among the most often used drugs, several have dual activity, against HIV and HBV: lamivudine, emtricitabine, tenofovir; they can be used as a combo, as tenofovir+emtricitabine for instance. Studies about vertical HBV transmission from HIV-HBV co-infected pregnant women are rare in developed countries. The study hypothesis is a major reduction of the risk of HBV vertical transmission in this context, justifying this retrospective study.

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

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
children born from HIV-HBV women		Studying retrospectively their status for HBs Ag and HBc Ab

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hepatitis B sAg status in children born from HIV-Hepatitis B Virus co-infected women		up to 10 years (expected average: 5 years)

Secondary Outcomes

Measure	Description	Time Frame
Antibodies (Ab) against Hepatitis B core antigen in children		up to 10 years (expected average: 5 years)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

children born in the Maternity Department from HIV-HBV co-infected women
whose mother was given a treatment with dual activity (HIV and HBV) during pregnancy

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Months

Maximum Age

15 Years

Standard Ages

Child

Study Population

All children born in the Maternity Department, Lariboisiere Hospital, Paris, France, from HIV-HBV co-infected women

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pierre O SELLIER, MD, PhD	Hopital Lariboisiere, Paris, France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Lariboisiere		Paris		75475	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26709883	Derived	Sellier PO, Schnepf N, Amarsy R, Maylin S, Lopes A, Mazeron MC, Flateau C, Morgand M, Ciraru-Vigneron N, Berthe A, Simoneau G, Evans J, Souak S, Matheron S, Benifla JL, Simon F, Bergmann JF. Short article: Hepatitis B virus status in children born to HIV/HBV coinfected women in a French hospital: a cross-sectional study. Eur J Gastroenterol Hepatol. 2016 Mar;28(3):328-32. doi: 10.1097/MEG.0000000000000559.