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临床试验/NCT02044068
NCT02044068已完成不适用

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.

Hopital Lariboisière1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
35
试验地点
1
主要终点
Hepatitis B sAg status in children born from HIV-Hepatitis B Virus co-infected women

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
9 Months 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

结局指标

主要结局

Hepatitis B sAg status in children born from HIV-Hepatitis B Virus co-infected women

时间窗: up to 10 years (expected average: 5 years)

次要结局

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

研究者

发起方
Hopital Lariboisière
申办方类型
Other
责任方
Principal Investigator
主要研究者

Célia Lloret-Linares, MD PhD

Professor at Paris VII Denis Diderot University, physician

Hopital Lariboisière

研究点 (1)

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