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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02044068

Enrollment

Registered

2014-01-23

Start date

2014-10-31

Completion date

2015-09-30

Last updated

2017-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HBV, Vertical Disease Transmission

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

9 Months to 15 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

France

Outcome results