National Cohort of Children Born to HIV-positive Mothers (EPF)

April 29, 2021 updated by: ANRS, Emerging Infectious Diseases

ANRS CO11 : National Cohort of Children Born to HIV-positive Mothers

The purpose of this study is to provide a surveillance system to monitor changes in the rate of mother to child HIV transmission and preventive practices in France and especially to identify the occurrence of toxicity in children exposed perinatally to antiretroviral drugs.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The goal of the CO11 national cohort is to provide with CO1 a wider surveillance system to monitor changes in the rate of mother to child transmission and preventive practices in France and especially to identify the occurrence of toxicity in children exposed perinatally to antiretroviral drugs.

The CO11 EPF enrolle HIV infected women who delivery in maternity generally smaller than CO1 maternity (15 sites in Paris area, 35 in mainland France and 4 in the DOM).

Maternal clinical, biological and therapeutic data before and during pregnancy were collected at delivery, with simplified questionnaires.

The children are examined clinically and biologically at birth, 6, 12 and 24 months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5200

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Amiens, France
        • Recruiting
        • CHU Hopital Nord
        • Contact:
          • Jean-Luc SCHMIT
        • Principal Investigator:
          • Jean-Luc SCHMIT
      • Angers, France
        • Recruiting
        • Centre Hospitalier Universitaire
        • Contact:
          • Pascale FIALAIRE
        • Principal Investigator:
          • Pascale FIALAIRE
      • Annecy, France
        • Recruiting
        • Centre Hosipitalier
        • Contact:
          • Virginie Vitrat
      • Aulnay, France
        • Recruiting
        • Centre Hospitalier Robert Ballanger
        • Contact:
          • Marie-Anne BOULDOUYRE
      • Bastia, France
        • Recruiting
        • Centre Hospitalier Général de Bastia
        • Contact:
          • Alice Moulin
        • Principal Investigator:
          • Alice Moulin
      • Bayonne, France
        • Recruiting
        • Centre Hospitalier de La Côte Basque
        • Contact:
          • Claudine CAYLA
        • Principal Investigator:
          • Claudine CAYLA
      • Besançon, France
        • Recruiting
        • CHRU Saint Jacques
      • Bordeaux, France
        • Recruiting
        • Groupe Hospitalier Pellegrin
        • Contact:
          • Christophe Elleau
        • Principal Investigator:
          • Christophe Elleau
      • Brest, France
        • Recruiting
        • Centre Hospitalier Regional Universitaire de Brest
        • Principal Investigator:
          • Séverine ANSART
      • Béziers, France
        • Recruiting
        • Centre Hospitalier de Béziers
        • Contact:
          • Gilles PALENZUELA
        • Principal Investigator:
          • Gilles PALENZUELA
      • Caen, France
        • Recruiting
        • CHRU Clémenceau
        • Principal Investigator:
          • Jacques BROUARD
      • Chalon sur Saone, France
        • Recruiting
        • Centre Hospitalier William Morey
        • Principal Investigator:
          • Sandrine Anne MARTHA
      • Creil, France
        • Recruiting
        • Centre Hospitalier Général
        • Contact:
          • Bénédicte Carpentier
        • Principal Investigator:
          • Bénédicte Carpentier
        • Sub-Investigator:
          • Etienne Dienga
      • Dijon, France
        • Recruiting
        • CHRU de Dijon
        • Contact:
          • Claire BRIANDET
        • Principal Investigator:
          • Claire BRIANDET
      • Evreux, France
        • Recruiting
        • Centre Hospitalier Général
        • Contact:
          • Johnson AMA
        • Principal Investigator:
          • Johnson AMA
      • Fontainebleau, France
        • Recruiting
        • Centre Hospitalier Général
        • Contact:
          • Corinne ROUTIER
        • Principal Investigator:
          • Corinne ROUTIER
      • La Roche sur Yon, France
        • Recruiting
        • Centre Hospitalier Les Oudayries
        • Contact:
          • Thomas GUIMARD
      • Lagny sur Marne, France
        • Recruiting
        • Centre Hospitalier de Lagny
        • Contact:
          • Armand CHALVON-DEMERSAY
        • Principal Investigator:
          • Armand CHALVON-DEMERSAY
      • Le Chesnay, France
        • Recruiting
        • Hôpital André Mignot, Versailles
      • Limoges, France
        • Recruiting
        • Centre Hospitalier Universitaire
      • Longjumeau, France
        • Recruiting
        • Centre Hospitalier Général
        • Contact:
          • Hervé SEAUME
        • Principal Investigator:
          • Hervé SEAUME
      • Lorient, France
        • Recruiting
        • Centre Hospitalier Bretagne Sud
        • Contact:
          • Mathilde Niault
        • Principal Investigator:
          • Mathilde Niault
      • Mantes la Jolie, France
        • Recruiting
        • Centre Hospitalier François Quesnay
      • Maux, France
        • Recruiting
        • Centre Hospitalier de Meaux
        • Contact:
          • Leila KARAOUI
        • Principal Investigator:
          • Leila KARAOUI
      • Melun, France
        • Recruiting
        • Centre Hospitalier Marc Jacquet
        • Contact:
          • Isolde PAULY-RAVELLY
      • Montfermeil, France
        • Recruiting
        • Centre Hospitalier Intercommunal
        • Contact:
          • Marion Dehlinger-Paul
        • Principal Investigator:
          • Marion Dehlinger-Paul
      • Nancy, France
        • Recruiting
        • CHU Nancy
        • Contact:
          • Claire HUBERT
        • Principal Investigator:
          • Claire HUBERT
      • Nîmes, France
        • Recruiting
        • CHU Caremeau
        • Contact:
          • Joëlle DENDALE-NGUYEN
        • Principal Investigator:
          • Joëlle DENDALE-NGUYEN
      • Orléans, France
        • Recruiting
        • Centre Hospitalier Regional
        • Contact:
          • Evelyne WERNER
        • Principal Investigator:
          • Evelyne WERNER
      • Orsay, France
        • Recruiting
        • Centre Hospitalier Général
        • Contact:
          • DE GENNES
        • Principal Investigator:
          • DE GENNES
      • Paris, France
        • Recruiting
        • Bon secours-Saint Joseph
        • Contact:
          • Marion Dehlinger-Paul
        • Principal Investigator:
          • Marion Dehlinger-Paul
      • Perpignan, France
        • Recruiting
        • CHG Maréchal Joffre
        • Contact:
          • Marie MEDUS
        • Principal Investigator:
          • Marie MEDUS
      • Poissy, France
        • Recruiting
        • Centre Hospitalier Intercommunal
        • Contact:
          • Sophie COUDERC
        • Principal Investigator:
          • Sophie COUDERC
      • Pontoise, France
        • Recruiting
        • Centre Hospitalier René Dubos
        • Contact:
          • Amine YANGUI
        • Principal Investigator:
          • Amine YANGUI
      • Provins, France
        • Recruiting
        • Centre Hospitalier Léon Binet
        • Contact:
          • Mohamed ABDELHADI
        • Principal Investigator:
          • Mohamed ABDELHADI
      • Quimper, France
        • Recruiting
        • Hopital Laennec
        • Contact:
          • Pascal PERFEZOU
        • Principal Investigator:
          • Pascal PERFEZOU
      • Reims, France
        • Recruiting
        • CHR American Memorial Hospital
        • Contact:
          • Claire PLUCHART
        • Principal Investigator:
          • Claire Pluchart
      • Rennes, France
        • Recruiting
        • Chu Pontchaillou
        • Principal Investigator:
          • Cédric ARVIEUX
      • Rouen, France
        • Recruiting
        • Hopital Charles Nicolle
        • Principal Investigator:
          • Didier PINQUIER
      • Saint Brieuc, France
        • Recruiting
        • Centre Hopsitalier Yves Le Foll
        • Contact:
          • Corinne DANIEL
        • Principal Investigator:
          • Corinne DANIEL
      • Saint Etienne, France
        • Recruiting
        • Hôpital Bellevue
        • Contact:
          • Kareen BILLEMAZ
        • Principal Investigator:
          • Kareen BILLEMAZ
      • Saint Julien, France
        • Recruiting
        • Centre hospitalier
        • Contact:
          • Emilie PIET
      • Saint Nazaire, France
        • Recruiting
        • Centre Hospitalier de Saint Nazaire-Cité Sanitaire
        • Contact:
          • Christophe Michaud
        • Principal Investigator:
          • Christophe Michaud
      • Saint-Martin, France
        • Recruiting
        • Hôpital de Saint-Martin
        • Contact:
          • Cyril CLAVEL
        • Principal Investigator:
          • Cyril CLAVEL
      • Toulon, France
        • Recruiting
        • Hopital Font Pré
        • Contact:
          • Gilles HITTINGER
      • Tours, France
        • Recruiting
        • Chru De Tours
      • Vannes, France
        • Recruiting
        • Centre Hospitalier Bretagne Atlantique
        • Contact:
          • Yves POINSIGNON
        • Principal Investigator:
          • Yves POINSIGNON
      • Vernon, France
        • Recruiting
        • Centre hospitalier
        • Contact:
          • Mahfoud ROUHA
        • Principal Investigator:
          • Mahfoud ROUHA
      • Villeneuve Saint Georges, France
        • Recruiting
        • Centre Hospitalier Intercommunal
        • Contact:
          • Anne CHACE
        • Principal Investigator:
          • Anne CHACE
  • French Guiana
      • Cayenne, French Guiana
        • Recruiting
        • CHG de Cayenne
        • Contact:
          • Narcisse ELENGA
        • Principal Investigator:
          • Narcisse Elenga
  • Guadeloupe
      • Pointe à Pitre, Guadeloupe
        • Recruiting
        • CHU Pointe à Pitre, Les Abymes
        • Contact:
          • Blandine MUANZA
        • Principal Investigator:
          • Blandine MUANZA
  • Martinique
      • Fort de France, Martinique
        • Recruiting
        • Hôpital Victor Fouche
        • Contact:
          • Yves HATCHUEL
        • Principal Investigator:
          • Yves HATCHUEL

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 obstetrical sites (15 sites in Paris area, 35 in mainland France and 4 in the DOM)

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • guardianship or judicial or administrative detention

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Efficacy of PMTCT strategies by measuring rate of mother to child transmission of HIV
Time Frame: At birth up to 24 months
Number of infected children (HIV RNA >50c/mL or Positive serology) reported on the total number of children
At birth up to 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Tolerance and toxicity of different kind of MTCT prophylaxis during pregnancy
Time Frame: At inclusion up to childbirth
incidence of pathologies during pregnancy
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

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ANRS, Emerging Infectious Diseases

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2005

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ANRS-CO11-EPF

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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