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