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

Completed

• Conditions: Vertical Disease Transmission; HBV

• Registration Number: NCT02044068
• Lead Sponsor: Hopital Lariboisière

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.

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 Timeline

• Study First Submitted: 2014-01-17
• Study First Submitted QC: 2014-01-21
• Study First Posted: 2014-01-23
• Study Start: 2014-10
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-26
• Last Update Posted: 2017-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hepatitis B sAg status in children born from HIV-Hepatitis B Virus co-infected women	up to 10 years (expected average: 5 years)

Secondary Outcome Measures

Name	Time	Method
Antibodies (Ab) against Hepatitis B core antigen in children	up to 10 years (expected average: 5 years)

Trial Locations

Locations (1)

Hopital Lariboisiere; 🇫🇷 Paris, France