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

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: Recruiting
• Conditions: 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.

• Study Type: Observational
• Enrollment (Anticipated): 5200

Contacts and Locations

• Study Contact: Name: Josiane WARSZAWSKI; Email: josiane.warszawski@inserm.fr
• Study Contact Backup: Name: Maud BROSSARD; Email: maud.brossard@inserm.fr

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 Beziers
    • 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

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 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

How is the study designed?

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	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

Outcome Measure	Measure Description	Time Frame
Immuno-virological response during pregnancy	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	incidence of pathologies during pregnancy	At inclusion up to childbirth
Impact of different kind of MTCT prophylaxis on childbirth	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	Clinical abnormalities (occurrence of adverse events)	At childbirth, 1 month, 3 months, 6 months, 12 months and 18-24 months

Collaborators and Investigators

• Sponsor: ANRS, Emerging Infectious Diseases

Publications and helpful links

General Publications

• Mandelbrot L, Tubiana R, Le Chenadec J, Dollfus C, Faye A, Pannier E, Matheron S, Khuong MA, Garrait V, Reliquet V, Devidas A, Berrebi A, Allisy C, Elleau C, Arvieux C, Rouzioux C, Warszawski J, Blanche S; ANRS-EPF Study Group. No perinatal HIV-1 transmission from women with effective antiretroviral therapy starting before conception. Clin Infect Dis. 2015 Dec 1;61(11):1715-25. doi: 10.1093/cid/civ578. Epub 2015 Jul 21.
• Taron-Brocard C, Le Chenadec J, Faye A, Dollfus C, Goetghebuer T, Gajdos V, Labaune JM, Perilhou A, Mandelbrot L, Blanche S, Warszawski J; France REcherche Nord&Sud Sida-HIV Hepatites - Enquete Perinatale Francaise - CO1/CO11 Study Group. Increased risk of serious bacterial infections due to maternal immunosuppression in HIV-exposed uninfected infants in a European country. Clin Infect Dis. 2014 Nov 1;59(9):1332-45. doi: 10.1093/cid/ciu586. Epub 2014 Jul 22.
• Sibiude J, Mandelbrot L, Blanche S, Le Chenadec J, Boullag-Bonnet N, Faye A, Dollfus C, Tubiana R, Bonnet D, Lelong N, Khoshnood B, Warszawski J. Association between prenatal exposure to antiretroviral therapy and birth defects: an analysis of the French perinatal cohort study (ANRS CO1/CO11). PLoS Med. 2014 Apr 29;11(4):e1001635. doi: 10.1371/journal.pmed.1001635. eCollection 2014 Apr.
• Briand N, Jasseron C, Sibiude J, Azria E, Pollet J, Hammou Y, Warszawski J, Mandelbrot L. Cesarean section for HIV-infected women in the combination antiretroviral therapies era, 2000-2010. Am J Obstet Gynecol. 2013 Oct;209(4):335.e1-335.e12. doi: 10.1016/j.ajog.2013.06.021. Epub 2013 Jun 18.
• Briand N, Warszawski J, Mandelbrot L, Dollfus C, Pannier E, Cravello L, Nguyen R, Matheron I, Winer N, Tubiana R, Rouzioux C, Faye A, Blanche S; ANRS-EPF CO1-CO11 Study Group. Is intrapartum intravenous zidovudine for prevention of mother-to-child HIV-1 transmission still useful in the combination antiretroviral therapy era? Clin Infect Dis. 2013 Sep;57(6):903-14. doi: 10.1093/cid/cit374. Epub 2013 May 31.
• Rachas A, Warszawski J, Le Chenadec J, Legeai C, Teglas JP, Goujard C, Rouzioux C, Mandelbrot L, Tubiana R, Meyer L. Does pregnancy affect the early response to cART? AIDS. 2013 Jan 28;27(3):357-67. doi: 10.1097/QAD.0b013e32835ac8bc.
• Jasseron C, Mandelbrot L, Dollfus C, Trocme N, Tubiana R, Teglas JP, Faye A, Rouzioux C, Blanche S, Warszawski J. Non-disclosure of a pregnant woman's HIV status to her partner is associated with non-optimal prevention of mother-to-child transmission. AIDS Behav. 2013 Feb;17(2):488-97. doi: 10.1007/s10461-011-0084-y.
• Simon A, Warszawski J, Kariyawasam D, Le Chenadec J, Benhammou V, Czernichow P, Foissac F, Laborde K, Treluyer JM, Firtion G, Layouni I, Munzer M, Bavoux F, Polak M, Blanche S; ANRS French Perinatal Cohort Study Group. Association of prenatal and postnatal exposure to lopinavir-ritonavir and adrenal dysfunction among uninfected infants of HIV-infected mothers. JAMA. 2011 Jul 6;306(1):70-8. doi: 10.1001/jama.2011.915.
• Sibiude J, Warszawski J, Tubiana R, Dollfus C, Faye A, Rouzioux C, Teglas JP, Ekoukou D, Blanche S, Mandelbrot L. Premature delivery in HIV-infected women starting protease inhibitor therapy during pregnancy: role of the ritonavir boost? Clin Infect Dis. 2012 May;54(9):1348-60. doi: 10.1093/cid/cis198. Epub 2012 Mar 28.
• Tubiana R, Le Chenadec J, Rouzioux C, Mandelbrot L, Hamrene K, Dollfus C, Faye A, Delaugerre C, Blanche S, Warszawski J. Factors associated with mother-to-child transmission of HIV-1 despite a maternal viral load <500 copies/ml at delivery: a case-control study nested in the French perinatal cohort (EPF-ANRS CO1). Clin Infect Dis. 2010 Feb 15;50(4):585-96. doi: 10.1086/650005.
• Briand N, Mandelbrot L, Le Chenadec J, Tubiana R, Teglas JP, Faye A, Dollfus C, Rouzioux C, Blanche S, Warszawski J; ANRS French Perinatal Cohort. No relation between in-utero exposure to HAART and intrauterine growth retardation. AIDS. 2009 Jun 19;23(10):1235-43. doi: 10.1097/QAD.0b013e32832be0df.
• Mandelbrot L, Jasseron C, Ekoukou D, Batallan A, Bongain A, Pannier E, Blanche S, Tubiana R, Rouzioux C, Warszawski J; ANRS French Perinatal Cohort (EPF). Amniocentesis and mother-to-child human immunodeficiency virus transmission in the Agence Nationale de Recherches sur le SIDA et les Hepatites Virales French Perinatal Cohort. Am J Obstet Gynecol. 2009 Feb;200(2):160.e1-9. doi: 10.1016/j.ajog.2008.08.049. Epub 2008 Nov 4.
• Jasseron C, Mandelbrot L, Tubiana R, Teglas JP, Faye A, Dollfus C, Le Chenadec J, Rouzioux C, Blanche S, Warszawski J; ANRS French Perinatal Cohort. Prevention of mother-to-child HIV transmission: similar access for sub-Sahara African immigrants and for French women? AIDS. 2008 Jul 31;22(12):1503-11. doi: 10.1097/QAD.0b013e3283065b8c.
• Benhammou V, Warszawski J, Bellec S, Doz F, Andre N, Lacour B, Levine M, Bavoux F, Tubiana R, Mandelbrot L, Clavel J, Blanche S; ANRS-Enquete Perinatale Francaise. Incidence of cancer in children perinatally exposed to nucleoside reverse transcriptase inhibitors. AIDS. 2008 Oct 18;22(16):2165-77. doi: 10.1097/QAD.0b013e328311d18b. Erratum In: AIDS. 2012 May 15;26(8):1047. Carbillon, Francois F [corrected to Carbillon, L].
• Warszawski J, Tubiana R, Le Chenadec J, Blanche S, Teglas JP, Dollfus C, Faye A, Burgard M, Rouzioux C, Mandelbrot L; ANRS French Perinatal Cohort. Mother-to-child HIV transmission despite antiretroviral therapy in the ANRS French Perinatal Cohort. AIDS. 2008 Jan 11;22(2):289-99. doi: 10.1097/QAD.0b013e3282f3d63c.

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Primary Completion (ANTICIPATED): March 1, 2023
• Study Completion (ANTICIPATED): March 1, 2023

Study Registration Dates

• First Submitted: September 20, 2016
• First Submitted That Met QC Criteria: October 4, 2017
• First Posted (ACTUAL): October 11, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 30, 2021
• Last Update Submitted That Met QC Criteria: April 29, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: HIV; Pregnancy; Prevention of mother-to-child transmission
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; HIV Seropositivity
• Other Study ID Numbers: ANRS-CO11-EPF