Prospective Observational Cohort Study on Mother to Child Transmission HIV1/HIV2 and Prevention

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Mother to Child Transmission of HIV

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pregnant women >= 18 years infected with HIV1 and/or HIV2 Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of PMTCT strategies by measuring rate of mother to child transmission of HIV | Number of infected children (HIV RNA >50c/mL or Positive serology) reported on the total number of children | At birth, 1 month, 3 months, 6 months, 12 months and 18-24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immuno-virological response during pregnancy | HIV ARN <50c/mL, CD4 cells count>500 cells/mL | At inclusion up to childbirth | 
| Tolerance and toxicity of different kind of MTCT prophylaxis during pregnancy | incidence of pathologies during pregnancy (Number of cases of preeclampsia, Number of cases of cholestasis, CDC stage) | At inclusion up to childbirth | 
| Impact of different kind of MTCT prophylaxis on childbirth | Childbirth mode (Number of emergency Caesarean section, Number of planned caesarean section) | At delivery | 
| Impact of different kind of MTCT prophylaxis during pregnancy on uninfected children | Clinical abnormalities (occurrence of adverse events) | At childbirth, 1 month, 3 months, 6 months, 12 months and 18-24 months | 
| Risk of mother-to-child transmission of VHC, VHB and CMV co-infections | Hepatitis B serology positive, Hepatitis C serology positive, presence of CMV in the urine | At birth, 6 months, 12 months and 18-24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Pregnancy, Prevention of mother-to-child transmission