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.

Study Timeline

• Study Start: 1997-07
• Study First Submitted: 2016-09-29
• Study First Submitted QC: 2017-07-27
• Study First Posted: 2017-08-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-12
• Last Update Posted: 2021-04-13
• Primary Completion: 2023-03
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 18200

Inclusion Criteria

• pregnant women >= 18 years
• infected with HIV1 and/or HIV2

Exclusion Criteria

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)

Centre Hospitalier Victor Dupuy; 🇫🇷 Argenteuil, France

Hôpital Jean Verdier; 🇫🇷 Bondy, France

Hôpital Antoine Béclère; 🇫🇷 Clamart, France

Hôpital de Beaujon; 🇫🇷 Clichy, France

Hôpital Louis Mourrier; 🇫🇷 Colombes, France

Centre Hospitalier Sud-Francilien; 🇫🇷 Corbeil-Essonnes, France

Centre Hospitalier Intercommunal; 🇫🇷 Montreuil, France

Hôpital Bicêtre; 🇫🇷 Le Kremlin Bicetre, France

CHR Jeanne de Flandres; 🇫🇷 Lille, France

Hôpital de La Croix Rousse; 🇫🇷 Lyon, France

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