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

NCT ID: NCT02044068

Last Updated: 2017-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Vertical Disease Transmission HBV

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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children born from HIV-HBV women

Studying retrospectively their status for HBs Ag and HBc Ab

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

9 Months

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hopital Lariboisière

OTHER

Sponsor Role lead

Responsible Party

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Célia Lloret-Linares, MD PhD

Professor at Paris VII Denis Diderot University, physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pierre O SELLIER, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hopital Lariboisiere, Paris, France

Locations

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Hopital Lariboisiere

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 26709883 (View on PubMed)

Other Identifiers

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Liver003

Identifier Type: -

Identifier Source: org_study_id

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