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临床试验/NCT03235310
NCT03235310Unknown不适用

ANRS CO1 EPF Prospective Observational Cohort Study on Mother-to-child Transmission HIV1 and/or HIV2 and Prevention

French National Agency for Research on AIDS and Viral Hepatitis27 个研究点 分布在 1 个国家目标入组 18,200 人开始时间: 1997年7月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
18,200
试验地点
27
主要终点
Efficacy of PMTCT strategies by measuring rate of mother to child transmission of HIV

研究概览

简要总结

The purpose of this study is to describe over time the rate of mother to child transmission of HIV and its prevention (PMTCT), to identify risk factors for transmission and to evaluate the safety of PMTCT strategies on outcome of pregnancy and in children not infected with HIV

详细描述

The CO1-EPF prospectively enrolled HIV-infected women who deliver in 25 centers throughout France, except in case of refusal.

Maternal clinical, biological and therapeutic data before and during pregnancy are collected at delivery. The children are examined clinically and biologically at birth, 1, 3, 6, 12 and 24 months. An infant is considered as non infected if two virologic tests are negative beyond the prophylactic treatment or serology is negative after 18 months. An infant is considered as infected if HIV1 is detected by virologic tests on two occasions (polymerase chain reactions, viral culture or p24 antigenemia) and if anti-HIV1 antibodies (ELISA and Western blot) persist after 18 months of age. Follow up is stopped at 24 months for uninfected infants whereas infected infants are enrolled in the CO10 EPF paediatric cohort. No specific recommendation for HIV treatment and obstetrical care are made for women and children included in the cohort, although national guidelines for prevention of MTCT are regularly published and updated. Frozen maternal samples blood and plasma are stored in a centralized laboratory. A research of patients patients lost to follow-up (last visit <24 months) and monitoring is performed regularly in all sites.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • pregnant women >= 18 years
  • infected with HIV1 and/or HIV2

排除标准

  • 未提供

结局指标

主要结局

Efficacy of PMTCT strategies by measuring rate of mother to child transmission of HIV

时间窗: At birth, 1 month, 3 months, 6 months, 12 months and 18-24 months

Number of infected children (HIV RNA \>50c/mL or Positive serology) reported on the total number of children

次要结局

  • Impact of different kind of MTCT prophylaxis during pregnancy on uninfected children(At childbirth, 1 month, 3 months, 6 months, 12 months and 18-24 months)
  • Immuno-virological response during pregnancy(At inclusion up to childbirth)
  • Risk of mother-to-child transmission of VHC, VHB and CMV co-infections(At birth, 6 months, 12 months and 18-24 months)
  • Impact of different kind of MTCT prophylaxis on childbirth(At delivery)
  • Tolerance and toxicity of different kind of MTCT prophylaxis during pregnancy(At inclusion up to childbirth)

研究者

发起方
French National Agency for Research on AIDS and Viral Hepatitis
申办方类型
Other Gov
责任方
Sponsor

研究点 (27)

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