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

April 12, 2021 updated by: French National Agency for Research on AIDS and Viral Hepatitis

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

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

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

18200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Argenteuil, France
        • Recruiting
        • Centre Hospitalier Victor Dupuy
        • Contact:
          • Philippe GENET
        • Principal Investigator:
          • Philippe GENET
        • Sub-Investigator:
          • Philippe BRAULT
      • Bondy, France
        • Recruiting
        • Hôpital Jean Verdier
        • Contact:
          • Eric LACHASSINE
        • Principal Investigator:
          • Eric LACHASSINE
        • Sub-Investigator:
          • Amélie BENBARA
        • Sub-Investigator:
          • Vincent JEANTILS
      • Clamart, France
        • Recruiting
        • Hôpital Antoine Béclère
        • Contact:
          • Véronique CHAMBRIN
        • Principal Investigator:
          • Véronique CHAMBRIN
        • Principal Investigator:
          • Laure CLECH
      • Clichy, France
        • Recruiting
        • Hôpital de Beaujon
        • Contact:
          • Pierre-François CECCALDI
        • Principal Investigator:
          • Pierre-François CECCALDI
      • Colombes, France
        • Recruiting
        • Hopital Louis Mourrier
        • Contact:
          • Catherine CRENN-HEBERT
        • Principal Investigator:
          • Catherine CRENN-HEBERT
        • Sub-Investigator:
          • Laurent MANDELBROT
        • Sub-Investigator:
          • Corinne FLOCH TUDAL
      • Corbeil-Essonnes, France
        • Recruiting
        • Centre Hospitalier Sud-Francilien
        • Contact:
          • Amélie CHABROL
        • Principal Investigator:
          • Amélie CHABROL
        • Sub-Investigator:
          • Michelle GRANIER
      • Creteil, France
        • Recruiting
        • Centre Hospitalier Intercommunal
        • Principal Investigator:
          • Valérie Garrait
        • Contact:
          • Valérie GARRAIT
        • Sub-Investigator:
          • Solène LEVET
        • Sub-Investigator:
          • Mariem BRIKA
      • Le Kremlin Bicetre, France
        • Recruiting
        • Hopital Bicetre
        • Contact:
          • Delphine PERETTI
        • Principal Investigator:
          • Delphine PERETTI
        • Sub-Investigator:
          • Claire COLMANT
        • Sub-Investigator:
          • Corinne FOURCADE
      • Lille, France
        • Recruiting
        • CHR Jeanne de Flandres
        • Contact:
          • Yamina HAMMOU
        • Principal Investigator:
          • Yamina HAMMOU
      • Lyon, France
        • Recruiting
        • Hopital de la Croix Rousse
        • Contact:
          • Laurent COTTE
        • Principal Investigator:
          • Laurent COTTE
        • Sub-Investigator:
          • Jean-Marc LABAUNE
      • Lyon, France
        • Recruiting
        • Hôpital Edouard Herriot
        • Contact:
          • Djamila MAKHLOUFI
        • Principal Investigator:
          • Djamila MAKHLOUFI
      • Lyon, France
        • Recruiting
        • Hopital Femme Mère Enfant
        • Principal Investigator:
          • Jérôme MASSARDIER
        • Sub-Investigator:
          • Hélène GAUTHIER-MOULINIER
      • Marseille, France
        • Recruiting
        • Hôpital de la Conception
        • Contact:
          • Ludovic CRAVELLO
        • Principal Investigator:
          • Ludovic CRAVELLO
      • Montpellier, France
        • Recruiting
        • CHR Arnaud de Villeneuve
        • Contact:
          • Emmanuelle VINTEJOUX
        • Principal Investigator:
          • Emmanuelle VINTEJOUX
        • Sub-Investigator:
          • Muriel LALANDE
      • Montreuil, France
        • Recruiting
        • Centre Hospitalier Intercommunal
        • Contact:
          • Brigitte HELLER - ROUSSIN
        • Principal Investigator:
          • Brigitte HELLER - ROUSSIN
        • Sub-Investigator:
          • Cécile WINTER
      • Nantes, France
        • Recruiting
        • Hotel Dieu
        • Contact:
          • Cécile BRUNET
        • Principal Investigator:
          • Cécile BRUNET
        • Sub-Investigator:
          • Véronique RELIQUET
        • Sub-Investigator:
          • Norbert WINER
      • Nice, France
        • Recruiting
        • CHU Hôpital de l'Archet II
        • Contact:
          • André BONGAIN
        • Principal Investigator:
          • André BONGAIN
        • Sub-Investigator:
          • Fabrice MONPOUX
      • Paris, France
        • Recruiting
        • Hôpital Trousseau
        • Contact:
          • Catherine DOLLFUS
        • Principal Investigator:
          • Catherine DOLLFUS
      • Paris, France
        • Recruiting
        • Hôpital Robert Debré
        • Contact:
          • Constance BORIE
        • Principal Investigator:
          • Constance BORIE
        • Sub-Investigator:
          • Albert FAYE
      • Paris, France
        • Recruiting
        • Hôpital Tenon
        • Contact:
          • Lise SELLERET
        • Principal Investigator:
          • Lise SELLERET
        • Sub-Investigator:
          • François HERVE
      • Paris, France
        • Recruiting
        • Hopital Lariboisiere
        • Contact:
          • Elodie GUESDON
        • Sub-Investigator:
          • Nicole CIRARU-VIGNERON
        • Principal Investigator:
          • Elodie GUESDON
        • Sub-Investigator:
          • Anne COURSOL
      • Paris, France
        • Recruiting
        • Groupe Hospitalier Pitié Salpétrière
        • Contact:
          • Roland TUBIANA
        • Principal Investigator:
          • Roland TUBIANA
        • Sub-Investigator:
          • Marc DOMMERGUES
        • Sub-Investigator:
          • Frédérique QUETIN
      • Paris, France
        • Recruiting
        • Groupe Hospitalier Cochin Tarnier Port-Royal
        • Contact:
          • Emmanuelle PANNIER
        • Principal Investigator:
          • Emmanuelle PANNIER
        • Sub-Investigator:
          • Dominique SALMON CERON
        • Sub-Investigator:
          • Valérie MARCOU
      • Paris, France
        • Recruiting
        • Groupe Hospitalier Necker
        • Contact:
          • Marine DRIESSEN
        • Principal Investigator:
          • Marine DRIESSEN
        • Sub-Investigator:
          • Stéphane BLANCHE
      • Paris, France
        • Recruiting
        • Hôpital Bichat- Claude Bernard
        • Principal Investigator:
          • Jade Ghosn
        • Contact:
          • Jade GHOSN
        • Sub-Investigator:
          • Agnès BOURGEOIS-MOINE
      • Saint-denis, France
        • Recruiting
        • Centre Hospitalier Général- Hôpital Delafontaine
        • Contact:
          • Pascal BOLOT
        • Principal Investigator:
          • Pascal BOLOT
        • Sub-Investigator:
          • Amel MAHDHI
      • Strasbourg, France
        • Recruiting
        • Hôpital Civil / Hôpital de Haute Pierre
        • Contact:
          • Maria Luisa PARTISANI
        • Principal Investigator:
          • Maria Luisa PARTISANI
        • Sub-Investigator:
          • Michelle WEIL
      • Toulouse, France
        • Recruiting
        • CHU Paule de Viguier
        • Contact:
          • Pierre DELOBEL
        • Principal Investigator:
          • Pierre DELOBEL
        • Sub-Investigator:
          • Noémie BIEZUNSKI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Inclusion as soon as possible during pregnancy of HIV-women in the largest obstetrical sites (17 in Paris area and 8 elsewhere in mainland France)

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of PMTCT strategies by measuring rate of mother to child transmission of HIV
Time Frame: 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
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
Time Frame: At inclusion up to childbirth
HIV ARN <50c/mL, CD4 cells count>500 cells/mL
At inclusion up to childbirth
Impact of different kind of MTCT prophylaxis on childbirth
Time Frame: At delivery
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
Time Frame: At childbirth, 1 month, 3 months, 6 months, 12 months and 18-24 months
Clinical abnormalities (occurrence of adverse events)
At childbirth, 1 month, 3 months, 6 months, 12 months and 18-24 months
Tolerance and toxicity of different kind of MTCT prophylaxis during pregnancy
Time Frame: At inclusion up to childbirth
incidence of pathologies during pregnancy (Number of cases of preeclampsia, Number of cases of cholestasis, CDC stage)
At inclusion up to childbirth
Risk of mother-to-child transmission of VHC, VHB and CMV co-infections
Time Frame: At birth, 6 months, 12 months and 18-24 months
Hepatitis B serology positive, Hepatitis C serology positive, presence of CMV in the urine
At birth, 6 months, 12 months and 18-24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French National Agency for Research on AIDS and Viral Hepatitis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1997

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

September 29, 2016

First Submitted That Met QC Criteria

July 27, 2017

First Posted (Actual)

August 1, 2017

Study Record Updates

Last Update Posted (Actual)

April 13, 2021

Last Update Submitted That Met QC Criteria

April 12, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ANRS-CO1-EPF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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