Prospective Observational Cohort Study on Mother to Child Transmission HIV1/HIV2 and Prevention
- Conditions
- Mother to Child Transmission of HIV
- Registration Number
- NCT03235310
- Lead Sponsor
- French National Agency for Research on AIDS and Viral Hepatitis
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 18200
- pregnant women >= 18 years
- infected with HIV1 and/or HIV2
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
Immuno-virological response during pregnancy At inclusion up to childbirth HIV ARN \<50c/mL, CD4 cells count\>500 cells/mL
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
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)
Trial Locations
- Locations (27)
H么tel Dieu
馃嚝馃嚪Nantes, France
H么pital Jean Verdier
馃嚝馃嚪Bondy, France
H么pital Antoine B茅cl猫re
馃嚝馃嚪Clamart, France
H么pital de Beaujon
馃嚝馃嚪Clichy, France
Centre Hospitalier Sud-Francilien
馃嚝馃嚪Corbeil-Essonnes, France
CHR Arnaud de Villeneuve
馃嚝馃嚪Montpellier, France
CHU H么pital de l'Archet II
馃嚝馃嚪Nice, France
H么pital Femme M猫re Enfant
馃嚝馃嚪Lyon, France
Centre Hospitalier Intercommunal
馃嚝馃嚪Montreuil, France
H么pital Bic锚tre
馃嚝馃嚪Le Kremlin Bicetre, France
CHR Jeanne de Flandres
馃嚝馃嚪Lille, France
H么pital Edouard Herriot
馃嚝馃嚪Lyon, France
Groupe Hospitalier Piti茅 Salp锚tri猫re
馃嚝馃嚪Paris, France
Centre Hospitalier Victor Dupuy
馃嚝馃嚪Argenteuil, France
H么pital Louis Mourrier
馃嚝馃嚪Colombes, France
H么pital de la conception
馃嚝馃嚪Marseille, France
H么pital de La Croix Rousse
馃嚝馃嚪Lyon, France
Groupe Hospitalier Cochin Tarnier Port-Royal
馃嚝馃嚪Paris, France
Groupe Hospitalier Necker
馃嚝馃嚪Paris, France
H么pital Robert Debr茅
馃嚝馃嚪Paris, France
CHU Paule de Viguier
馃嚝馃嚪Toulouse, France
H么pital Tenon
馃嚝馃嚪Paris, France
H么pital Trousseau
馃嚝馃嚪Paris, France
Centre Hospitalier G茅n茅ral- H么pital Delafontaine
馃嚝馃嚪Saint-denis, France
H么pital Civil / H么pital de Haute Pierre
馃嚝馃嚪Strasbourg, France
H么pital Bichat- Claude Bernard
馃嚝馃嚪Paris, France
H么pital Lariboisi猫re
馃嚝馃嚪Paris, France