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Clinical Trials

MainTitle

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

This study is currently recruiting participants. (see Contacts and Locations)

Verified September 2016 by French National Agency for Research on AIDS and Viral Hepatitis

Sponsor
French National Agency for Research on AIDS and Viral Hepatitis


Information provided by (Responsible Party)
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier
NCT03235310

First received: September 29, 2016
Last updated: July 27, 2017
Last Verified: September 2016
History of Changes
Purpose

Purpose

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

Condition
Mother to Child Transmission of HIV

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: ANRS CO1 EPF Prospective Observational Cohort Study on Mother-to-child Transmission HIV1 and/or HIV2 and Prevention

Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures

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

Biospecimen Retention: Samples Without DNA
3 mL whole blood 3mL plasma

Estimated Enrollment: 18200
Study Start Date: July 1997
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
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 the largest obstetrical sites (17 in Paris area and 8 elsewhere in mainland France)

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

contacts and locations

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03235310

Contacts

Contact:   Josiane Warszawski 01 49 59 53 05 josiane.warszawski@inserm.fr
Contact:   Olivia Dialla 01 49 59 53 13 pegdwende-olivia.dialla@inserm.fr

Locations

France
Centre Hospitalier Victor Dupuy Recruiting
Argenteuil, France
Contact: Philippe GENET
Principal Investigator: Philippe GENET
Sub-Investigator: Philippe BRAULT
Hôpital Jean Verdier Recruiting
Bondy, France
Contact: Eric LACHASSINE
Principal Investigator: Eric LACHASSINE
Sub-Investigator: Amélie BENBARA
Sub-Investigator: Vincent JEANTILS
Hôpital Antoine Béclère Recruiting
Clamart, France
Contact: Véronique CHAMBRIN
Principal Investigator: Véronique CHAMBRIN
Principal Investigator: Laure CLECH
Hôpital de Beaujon Recruiting
Clichy, France
Contact: Pierre-François CECCALDI
Principal Investigator: Pierre-François CECCALDI
Hôpital Louis Mourrier Recruiting
Colombes, France
Contact: Catherine CRENN-HEBERT
Principal Investigator: Catherine CRENN-HEBERT
Sub-Investigator: Laurent MANDELBROT
Centre Hospitalier Sud-Francilien Recruiting
Corbeil Essonne, France
Contact: Alain DEVIDAS
Principal Investigator: Alain DEVIDAS
Sub-Investigator: Rose NGUYEN
Sub-Investigator: Michelle GRANIER
Centre Hospitalier Intercommunal Recruiting
Creteil, France
Contact: Valérie GARRAIT
Principal Investigator: Valérie GARRAIT
Sub-Investigator: Claudine TOUBOUL
Hôpital Bicêtre Recruiting
Le Kremlin Bicetre, France
Contact: Delphine PERETTI
Principal Investigator: Delphine PERETTI
Sub-Investigator: Claire COLMANT
Sub-Investigator: Corinne FOURCADE
CHR Jeanne de Flandres Recruiting
Lille, France
Contact: Françoise MAZINGUE
Principal Investigator: Françoise MAZINGUE
Sub-Investigator: Yamina HAMMOU
Hôpital de La Croix Rousse Recruiting
Lyon, France
Contact: Laurent COTTE
Principal Investigator: Laurent COTTE
Sub-Investigator: Jean-Marc LABAUNE
Hôpital Edouard Herriot Recruiting
Lyon, France
Contact: Djamila MAKHLOUFI
Principal Investigator: Djamila MAKHLOUFI
Hôpital Femme Mère Enfant Recruiting
Lyon, France
Contact: Jérôme MASSARDIER
Principal Investigator: Jérôme MASSARDIER
Sub-Investigator: Hélène GAUTHIER-MOULINIER
Hôpital de la conception Recruiting
Marseille, France
Contact: Ludovic CRAVELLO
Principal Investigator: Ludovic CRAVELLO
CHR Arnaud de Villeneuve Recruiting
Montpellier, France
Contact: Emmanuelle VINTEJOUX
Principal Investigator: Emmanuelle VINTEJOUX
Sub-Investigator: Muriel LALANDE
Centre Hospitalier Intercommunal Recruiting
Montreuil, France
Contact: Brigitte HELLER - ROUSSIN
Principal Investigator: Brigitte HELLER - ROUSSIN
Sub-Investigator: Cécile WINTER
Hôtel Dieu Recruiting
Nantes, France
Contact: Cécile BRUNET
Principal Investigator: Cécile BRUNET
Sub-Investigator: Véronique RELIQUET
Sub-Investigator: Norbert WINER
CHU Hôpital de l'Archet II Recruiting
Nice, France
Contact: André BONGAIN
Principal Investigator: André BONGAIN
Sub-Investigator: Fabrice MONPOUX
Groupe Hospitalier Cochin Tarnier Port-Royal Recruiting
Paris, France
Contact: Emmanuelle PANNIER
Principal Investigator: Emmanuelle PANNIER
Sub-Investigator: Dominique SALMON CERON
Groupe Hospitalier Necker Recruiting
Paris, France
Contact: Marine DRIESSEN
Principal Investigator: Marine DRIESSEN
Sub-Investigator: Stéphane BLANCHE
Groupe Hospitalier Pitié Salpêtrière Recruiting
Paris, France
Contact: Roland TUBIANA
Principal Investigator: Roland TUBIANA
Sub-Investigator: Marc DOMMERGUES
Sub-Investigator: Frédérique QUETIN
Hôpital Bichat- Claude Bernard Recruiting
Paris, France
Contact: Sophie MATHERON
Principal Investigator: Sophie MATHERON
Sub-Investigator: Agnès BOURGEOIS-MOINE
Hôpital Lariboisière Recruiting
Paris, France
Contact: Nicole CIRARU-VIGNERON
Principal Investigator: Nicole CIRARU-VIGNERON
Hôpital Robert Debré Recruiting
Paris, France
Contact: Sophie MATHERON
Principal Investigator: Sophie MATHERON
Hôpital Tenon Recruiting
Paris, France
Contact: Marie-Gisèle LEBRETTE
Principal Investigator: Marie-Gisèle LEBRETTE
Sub-Investigator: François HERVE
Hôpital Trousseau Recruiting
Paris, France
Contact: Catherine DOLLFUS
Principal Investigator: Catherine DOLLFUS
Centre Hospitalier Général- Hôpital Delafontaine Recruiting
Saint-denis, France
Contact: Pascal BOLOT
Principal Investigator: Pascal BOLOT
Sub-Investigator: Amel MAHDHI
Hôpital Civil / Hôpital de Haute Pierre Recruiting
Strasbourg, France
Contact: Maria Luisa PARTISANI
Principal Investigator: Maria Luisa PARTISANI
Sub-Investigator: Michelle WEIL
CHU Paule de Viguier Recruiting
Toulouse, France
Contact: Caroline SIMON-TOULZA
Principal Investigator: Caroline SIMON-TOULZA
Sub-Investigator: Joelle TRICOIRE

Sponsors and Collaborators

French National Agency for Research on AIDS and Viral Hepatitis

Investigators

Principal Investigator: Josiane Warszawski CESP INSERM U1018
More Information

More Information


Responsible Party: French National Agency for Research on AIDS and Viral Hepatitis  
ClinicalTrials.gov Identifier: NCT03235310   History of Changes  
Other Study ID Numbers: ANRS-CO1-EPF  
Study First Received: September 29, 2016  
Last Updated: July 27, 2017  

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

HIV
Pregnancy
Prevention of mother-to-child transmission

ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.