We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03306251
Recruitment Status : Recruiting
First Posted : October 11, 2017
Last Update Posted : April 30, 2021
Sponsor:
Information provided by (Responsible Party):
ANRS, Emerging Infectious Diseases

Brief Summary:
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.

Condition or disease
Mother to Child Transmission of HIV

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 5200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ANRS CO11 : National Cohort of Children Born to HIV-positive Mothers
Study Start Date : June 2005
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Immuno-virological response during pregnancy [ Time Frame: At inclusion up to childbirth ]
    HIV ARN <50c/mL, CD4 cells count>500 cells/mL

  2. Tolerance and toxicity of different kind of MTCT prophylaxis during pregnancy [ Time Frame: At inclusion up to childbirth ]
    incidence of pathologies during pregnancy

  3. 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)

  4. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • guardianship or judicial or administrative detention

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03306251


Contacts
Layout table for location contacts
Contact: Josiane WARSZAWSKI josiane.warszawski@inserm.fr
Contact: Maud BROSSARD maud.brossard@inserm.fr

Locations
Show Show 52 study locations
Sponsors and Collaborators
ANRS, Emerging Infectious Diseases
Investigators
Layout table for investigator information
Principal Investigator: Josiane WARSZAWSKI CESP INSERM U1018
Publications of Results:

Layout table for additonal information
Responsible Party: ANRS, Emerging Infectious Diseases
ClinicalTrials.gov Identifier: NCT03306251    
Other Study ID Numbers: ANRS-CO11-EPF
First Posted: October 11, 2017    Key Record Dates
Last Update Posted: April 30, 2021
Last Verified: April 2021
Keywords provided by ANRS, Emerging Infectious Diseases:
HIV
Pregnancy
Prevention of mother-to-child transmission
Additional relevant MeSH terms:
Layout table for MeSH terms
HIV Seropositivity
HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases