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

January 17, 2014
January 21, 2014
March 2014
July 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT02044068 on ClinicalTrials.gov Archive Site
Antibodies (Ab) against Hepatitis B core antigen in children [ Time Frame: up to 10 years (expected average: 5 years) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Hepatitis B Virus Vertical Transmission From HIV-HBV Co-infected Women
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.

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Vertical Disease Transmission
  • HBV
Not Provided
children born from HIV-HBV women
Studying retrospectively their status for HBs Ag and HBc Ab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
60
July 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
9 Months to 15 Years
No
Contact: Pierre O SELLIER, MD, PhD 00 33 149956339 pierre.sellier@lrb.aphp.fr
France
 
NCT02044068
Liver003
No
Stephane Mouly, MD PhD, Hopital Lariboisière
Hopital Lariboisière
Not Provided
Principal Investigator: Pierre O SELLIER, MD, PhD Hopital Lariboisiere, Paris, France
Hopital Lariboisière
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP