NCT02044068

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 17, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 23, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

April 28, 2017

Status Verified

April 1, 2017

Enrollment Period

11 months

First QC Date

January 17, 2014

Last Update Submit

April 26, 2017

Conditions

Vertical Disease TransmissionHBV

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Antibodies (Ab) against Hepatitis B core antigen in children

    up to 10 years (expected average: 5 years)

Study Arms (1)

children born from HIV-HBV women

Studying retrospectively their status for HBs Ag and HBc Ab

Eligibility Criteria

Age9 Months - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Lariboisiere

Paris, 75475, France

Location

Related Publications (1)

  • 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.

    PMID: 26709883DERIVED

Study Officials

  • Pierre O SELLIER, MD, PhD

    Hopital Lariboisiere, Paris, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor at Paris VII Denis Diderot University, physician

Study Record Dates

First Submitted

January 17, 2014

First Posted

January 23, 2014

Study Start

October 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

April 28, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)