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

Last updated: April 12, 2021
Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03235310
ANRS-CO1-EPF
  • Ages > 18
  • Female

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

Study Design

Total Participants: 18200
Study Start date:
July 01, 1997
Estimated Completion Date:
March 31, 2023

Study 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.

Connect with a study center

  • Centre Hospitalier Victor Dupuy

    Argenteuil,
    France

    Active - Recruiting

  • Hôpital Jean Verdier

    Bondy,
    France

    Active - Recruiting

  • Hôpital Antoine Béclère

    Clamart,
    France

    Active - Recruiting

  • Hôpital de Beaujon

    Clichy,
    France

    Active - Recruiting

  • Hôpital Louis Mourrier

    Colombes,
    France

    Active - Recruiting

  • Centre Hospitalier Sud-Francilien

    Corbeil Essonne,
    France

    Site Not Available

  • Centre Hospitalier Sud-Francilien

    Corbeil-Essonnes,
    France

    Active - Recruiting

  • Centre Hospitalier Intercommunal

    Creteil,
    France

    Active - Recruiting

  • Hôpital Bicêtre

    Le Kremlin Bicetre,
    France

    Active - Recruiting

  • CHR Jeanne de Flandres

    Lille,
    France

    Active - Recruiting

  • Hôpital Edouard Herriot

    Lyon,
    France

    Active - Recruiting

  • Hôpital Femme Mère Enfant

    Lyon,
    France

    Active - Recruiting

  • Hôpital de La Croix Rousse

    Lyon,
    France

    Active - Recruiting

  • Hôpital de la conception

    Marseille,
    France

    Active - Recruiting

  • CHR Arnaud de Villeneuve

    Montpellier,
    France

    Active - Recruiting

  • Centre Hospitalier Intercommunal

    Montreuil,
    France

    Active - Recruiting

  • Hôtel Dieu

    Nantes,
    France

    Active - Recruiting

  • CHU Hôpital de l'Archet II

    Nice,
    France

    Active - Recruiting

  • Groupe Hospitalier Cochin Tarnier Port-Royal

    Paris,
    France

    Active - Recruiting

  • Groupe Hospitalier Necker

    Paris,
    France

    Active - Recruiting

  • Groupe Hospitalier Pitié Salpêtrière

    Paris,
    France

    Active - Recruiting

  • Hôpital Bichat- Claude Bernard

    Paris,
    France

    Active - Recruiting

  • Hôpital Lariboisière

    Paris,
    France

    Active - Recruiting

  • Hôpital Robert Debré

    Paris,
    France

    Active - Recruiting

  • Hôpital Tenon

    Paris,
    France

    Active - Recruiting

  • Hôpital Trousseau

    Paris,
    France

    Active - Recruiting

  • Centre Hospitalier Général- Hôpital Delafontaine

    Saint-denis,
    France

    Active - Recruiting

  • Hôpital Civil / Hôpital de Haute Pierre

    Strasbourg,
    France

    Active - Recruiting

  • CHU Paule de Viguier

    Toulouse,
    France

    Active - Recruiting

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