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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Célia Lloret-Linares, MD PhD, Hopital Lariboisière
ClinicalTrials.gov Identifier:
NCT02044068
First received: January 17, 2014
Last updated: April 26, 2017
Last verified: April 2017
January 17, 2014
April 26, 2017
October 2014
September 2015   (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) ]
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) ]
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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
September 2015
September 2015   (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:

Sexes Eligible for Study: All
9 Months to 15 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT02044068
Liver003
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Célia Lloret-Linares, MD PhD, Hopital Lariboisière
Hopital Lariboisière
Not Provided
Principal Investigator: Pierre O SELLIER, MD, PhD Hopital Lariboisiere, Paris, France
Hopital Lariboisière
April 2017

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