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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02044068
Recruitment Status : Completed
First Posted : January 23, 2014
Last Update Posted : April 28, 2017
Sponsor:
Information provided by (Responsible Party):

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
Vertical Disease Transmission HBV

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 : October 2014
Primary Completion Date : September 2015
Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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 [ Time Frame: up to 10 years (expected average: 5 years) ]

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Months to 15 Years   (Child)
Sexes Eligible for Study:   All
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:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02044068


Locations
France
Hopital Lariboisiere
Paris, France, 75475
Sponsors and Collaborators
Hopital Lariboisière
Investigators
Principal Investigator: Pierre O SELLIER, MD, PhD Hopital Lariboisiere, Paris, France
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Célia Lloret-Linares, MD PhD, Professor at Paris VII Denis Diderot University, physician, Hopital Lariboisière
ClinicalTrials.gov Identifier: NCT02044068     History of Changes
Other Study ID Numbers: Liver003
First Posted: January 23, 2014    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
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
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis
Liver Diseases
Digestive System Diseases