Mother to Child Transmission of HIV
Conditions
Keywords
HIV, Pregnancy, Prevention of mother-to-child transmission
Brief summary
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
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.
Interventions
None listed
Sponsors
French National Agency for Research on AIDS and Viral Hepatitis
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* pregnant women \>= 18 years * infected with HIV1 and/or HIV2
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of PMTCT strategies by measuring rate of mother to child transmission of HIV | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immuno-virological response during pregnancy | At inclusion up to childbirth | HIV ARN \<50c/mL, CD4 cells count\>500 cells/mL |
| Tolerance and toxicity of different kind of MTCT prophylaxis during pregnancy | At inclusion up to childbirth | incidence of pathologies during pregnancy (Number of cases of preeclampsia, Number of cases of cholestasis, CDC stage) |
| Impact of different kind of MTCT prophylaxis on childbirth | At delivery | Childbirth mode (Number of emergency Caesarean section, Number of planned caesarean section) |
| 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 | Clinical abnormalities (occurrence of adverse events) |
| Risk of mother-to-child transmission of VHC, VHB and CMV co-infections | At birth, 6 months, 12 months and 18-24 months | Hepatitis B serology positive, Hepatitis C serology positive, presence of CMV in the urine |
Countries
France
Contacts
Primary ContactJosiane Warszawski
Backup ContactMaud BROSSARD
Outcome results
None listed