ANRS CO11 : National Cohort of Children Born to HIV-positive Mothers
试验速览
- 阶段
- 不适用
- 入组人数
- 5,200
- 试验地点
- 45
- 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 provide a surveillance system to monitor changes in the rate of mother to child HIV transmission and preventive practices in France and especially to identify the occurrence of toxicity in children exposed perinatally to antiretroviral drugs.
详细描述
The goal of the CO11 national cohort is to provide with CO1 a wider surveillance system to monitor changes in the rate of mother to child transmission and preventive practices in France and especially to identify the occurrence of toxicity in children exposed perinatally to antiretroviral drugs.
The CO11 EPF enrolle HIV infected women who delivery in maternity generally smaller than CO1 maternity (15 sites in Paris area, 35 in mainland France and 4 in the DOM).
Maternal clinical, biological and therapeutic data before and during pregnancy were collected at delivery, with simplified questionnaires.
The children are examined clinically and biologically at birth, 6, 12 and 24 months.
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
- 否
入选标准
- •pregnant women >= 18 years
- •infected with HIV1 and/or HIV2
排除标准
- •guardianship or judicial or administrative detention
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 up to 24 months
Number of infected children (HIV RNA \>50c/mL or Positive serology) reported on the total number of children
次要结局
- Immuno-virological response during pregnancy(At inclusion up to childbirth)
- 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)
- 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)