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

This study is not yet open for participant recruitment. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014