Clincosm LogoSign in Get a demo

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

Sponsor
Hopital Lariboisière (Other)
Overall Status
Completed
CT.gov ID
NCT02044068
Collaborator
(none)
35
Enrollment
1
Location
11
Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    35 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Prevention of Hepatitis B Virus Mother-to-Child Transmission (MTCT) From HIV-HBV Co-infected Pregnant Women by Use of Nucleosides/Nucleotides Analogues With Dual Activity During Pregnancy.
    Study Start Date :
    Oct 1, 2014
    Actual Primary Completion Date :
    Sep 1, 2015
    Actual Study Completion Date :
    Sep 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    children born from HIV-HBV women

    Studying retrospectively their status for HBs Ag and HBc Ab

    Outcome Measures

    Primary Outcome Measures

    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 Outcome Measures

    1. Antibodies (Ab) against Hepatitis B core antigen in children [up to 10 years (expected average: 5 years)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    9 Months to 15 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:
    • no

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hopital Lariboisiere Paris France 75475

    Sponsors and Collaborators

    • Hopital Lariboisière

    Investigators

    • Principal Investigator: Pierre O SELLIER, MD, PhD, Hopital Lariboisiere, Paris, France

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Célia Lloret-Linares, MD PhD, Professor at Paris VII Denis Diderot University, physician, Hopital Lariboisière
    ClinicalTrials.gov Identifier:
    NCT02044068
    Other Study ID Numbers:
    • Liver003
    First Posted:
    Jan 23, 2014
    Last Update Posted:
    Apr 28, 2017
    Last Verified:
    Apr 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hepatitis B

    Study Results

    No Results Posted as of Apr 28, 2017