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

HBV Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02044068
• Other study ID #: Liver003
• Status: Completed
• Phase: N/A
• First received: January 17, 2014
• Last updated: April 26, 2017
• Start date: October 2014
• Est. completion date: September 2015

Study information

• Verified date: April 2017
• Source: Hopital Lariboisière
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Months to 15 Years

Eligibility

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:

Related Conditions & MeSH terms

• HBV
• Hepatitis B
• Vertical Disease Transmission

Locations

Country	Name	City	State
France	Hopital Lariboisiere	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Lariboisière

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatitis B sAg status in children born from HIV-Hepatitis B Virus co-infected women		up to 10 years (expected average: 5 years)
Secondary	Antibodies (Ab) against Hepatitis B core antigen in children		up to 10 years (expected average: 5 years)