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

This study is not yet open for participant recruitment.
Verified January 2014 by Hopital Lariboisière
Sponsor:
Information provided by (Responsible Party):
Stephane Mouly, MD PhD, Hopital Lariboisière
ClinicalTrials.gov Identifier:
NCT02044068
First received: January 17, 2014
Last updated: January 21, 2014
Last verified: January 2014
  Purpose

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
Vertical Disease Transmission
HBV

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Hopital Lariboisière:

Primary Outcome Measures:
  • Hepatitis B sAg status in children born from HIV-Hepatitis B Virus co-infected women [ Time Frame: up to 10 years (expected average: 5 years) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Antibodies (Ab) against Hepatitis B core antigen in children [ Time Frame: up to 10 years (expected average: 5 years) ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2014
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
children born from HIV-HBV women
Studying retrospectively their status for HBs Ag and HBc Ab

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.

  Eligibility

Ages Eligible for Study:   9 Months to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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:

  • no
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02044068

Contacts
Contact: Pierre O SELLIER, MD, PhD 00 33 149956339 pierre.sellier@lrb.aphp.fr

Locations
France
Hopital Lariboisiere Not yet recruiting
Paris, France, 75475
Contact: Pierre O SELLIER, MD, PhD    00 33 149956339    pierre.sellier@lrb.aphp.fr   
Sponsors and Collaborators
Hopital Lariboisière
Investigators
Principal Investigator: Pierre O SELLIER, MD, PhD Hopital Lariboisiere, Paris, France
  More Information

No publications provided

Responsible Party: Stephane Mouly, MD PhD, Professor at Paris VII Denis Diderot University, physician, Hopital Lariboisière
ClinicalTrials.gov Identifier: NCT02044068     History of Changes
Other Study ID Numbers: Liver003
Study First Received: January 17, 2014
Last Updated: January 21, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on April 16, 2014