ClinicalTrials.gg
Status unknownNCT03306251EPFUpdated Apr 30, 2021

National Cohort of Children Born to HIV-positive Mothers

An observational study in Mother to Child Transmission of HIV, sponsored by ANRS, Emerging Infectious Diseases. Status unknown at 52 sites in 4 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-30.

Sponsored by ANRS, Emerging Infectious Diseases · Observational

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,200
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Mother to Child Transmission of HIV

Keywords

  • HIV
  • Pregnancy
  • Prevention of mother-to-child transmission
03

In context

Lead sponsor

ANRS, Emerging Infectious Diseases is the lead sponsor of 215 studies on the registry; 38 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • guardianship or judicial or administrative detention
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,200 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: At birth up to 24 months

Secondary outcomes

  1. Immuno-virological response during pregnancy

    HIV ARN \<50c/mL, CD4 cells count\>500 cells/mL

    Time frame: At inclusion up to childbirth

  2. Tolerance and toxicity of different kind of MTCT prophylaxis during pregnancy

    incidence of pathologies during pregnancy

    Time frame: At inclusion up to childbirth

  3. Impact of different kind of MTCT prophylaxis on childbirth

    Childbirth mode (Number of emergency Caesarean section, Number of planned caesarean section)

    Time frame: At delivery

  4. Impact of different kind of MTCT prophylaxis during pregnancy on uninfected children

    Clinical abnormalities (occurrence of adverse events)

    Time frame: At childbirth, 1 month, 3 months, 6 months, 12 months and 18-24 months

07

Study locations

52 of 52 sites recruiting
  • CHU Hôpital Nord
    Amiens, France
    Recruiting
    • Jean-Luc SCHMIT · Contact
    • Jean-Luc SCHMIT · Principal investigator
  • Centre Hospitalier Universitaire
    Angers, France
    Recruiting
    • Pascale FIALAIRE · Contact
    • Pascale FIALAIRE · Principal investigator
  • Centre Hosipitalier
    Annecy, France
    Recruiting
    • Virginie Vitrat · Contact
    • Virginie Vitrat · Principal investigator
  • Centre Hospitalier Robert Ballanger
    Aulnay, France
    Recruiting
    • Marie-Anne BOULDOUYRE · Contact
  • Centre Hospitalier Général de Bastia
    Bastia, France
    Recruiting
    • Alice Moulin · Contact
    • Alice Moulin · Principal investigator
  • Centre Hospitalier de la Côte Basque
    Bayonne, France
    Recruiting
    • Claudine CAYLA · Contact
    • Claudine CAYLA · Principal investigator
  • CHRU Saint Jacques
    Besançon, France
    Recruiting
    • Catherine CHIROUZE · Contact
    • Catherine CHIROUZE · Principal investigator
  • Groupe Hospitalier Pellegrin
    Bordeaux, France
    Recruiting
    • Christophe Elleau · Contact
    • Christophe Elleau · Principal investigator
  • Centre Hospitalier Régional Universitaire de Brest
    Brest, France
    Recruiting
    • Séverine ANSART · Contact
    • Séverine ANSART · Principal investigator
  • Centre hospitalier de Béziers
    Béziers, France
    Recruiting
    • Gilles PALENZUELA · Contact
    • Gilles PALENZUELA · Principal investigator
  • CHRU Clemenceau
    Caen, France
    Recruiting
    • Jacques BROUARD · Contact
    • Jacques BROUARD · Principal investigator
  • Centre Hospitalier William Morey
    Chalon sur Saone, France
    Recruiting
    • Sandrine Anne MARTHA · Contact
    • Sandrine Anne MARTHA · Principal investigator
  • Centre Hospitalier Général
    Creil, France
    Recruiting
    • Bénédicte Carpentier · Contact
    • Bénédicte Carpentier · Principal investigator
    • Etienne Dienga · Sub investigator
  • CHRU de Dijon
    Dijon, France
    Recruiting
    • Claire BRIANDET · Contact
    • Claire BRIANDET · Principal investigator
  • Centre Hospitalier Général
    Evreux, France
    Recruiting
    • Johnson AMA · Contact
    • Johnson AMA · Principal investigator
  • Centre Hospitalier Général
    Fontainebleau, France
    Recruiting
    • Corinne ROUTIER · Contact
    • Corinne ROUTIER · Principal investigator
  • Centre Hospitalier Les Oudayries
    La Roche sur Yon, France
    Recruiting
    • Thomas GUIMARD · Contact
    • Thomas GUIMARD · Principal investigator
  • Centre Hospitalier de Lagny
    Lagny sur Marne, France
    Recruiting
    • Armand CHALVON-DEMERSAY · Contact
    • Armand CHALVON-DEMERSAY · Principal investigator
  • Hôpital André Mignot, Versailles
    Le Chesnay, France
    Recruiting
    • Véronique HENTGEN · Contact
    • Véronique HENTGEN · Principal investigator
  • Centre Hospitalier Universitaire
    Limoges, France
    Recruiting
    • Claire GENET · Contact
    • Claire GENET · Principal investigator
  • Centre Hospitalier Général
    Longjumeau, France
    Recruiting
    • Hervé SEAUME · Contact
    • Hervé SEAUME · Principal investigator
  • Centre Hospitalier Bretagne Sud
    Lorient, France
    Recruiting
    • Mathilde Niault · Contact
    • Mathilde Niault · Principal investigator
  • Centre Hospitalier François Quesnay
    Mantes la Jolie, France
    Recruiting
    • Ahmed JABBAR · Contact
    • Ahmed JABBAR · Principal investigator
  • Centre Hospitalier de Meaux
    Maux, France
    Recruiting
    • Leila KARAOUI · Contact
    • Leila KARAOUI · Principal investigator
  • Centre Hospitalier Marc Jacquet
    Melun, France
    Recruiting
    • Isolde PAULY-RAVELLY · Contact
  • Centre Hospitalier Intercommunal
    Montfermeil, France
    Recruiting
    • Marion Dehlinger-Paul · Contact
    • Marion Dehlinger-Paul · Principal investigator
  • CHU Nancy
    Nancy, France
    Recruiting
    • Claire HUBERT · Contact
    • Claire HUBERT · Principal investigator
  • CHU Caremeau
    Nîmes, France
    Recruiting
    • Joëlle DENDALE-NGUYEN · Contact
    • Joëlle DENDALE-NGUYEN · Principal investigator
  • Centre Hospitalier Régional
    Orléans, France
    Recruiting
    • Evelyne WERNER · Contact
    • Evelyne WERNER · Principal investigator
  • Centre Hospitalier Général
    Orsay, France
    Recruiting
    • DE GENNES · Contact
    • DE GENNES · Principal investigator
  • Bon secours-Saint Joseph
    Paris, France
    Recruiting
    • Marion Dehlinger-Paul · Contact
    • Marion Dehlinger-Paul · Principal investigator
  • CHG Maréchal Joffre
    Perpignan, France
    Recruiting
    • Marie MEDUS · Contact
    • Marie MEDUS · Principal investigator
  • Centre Hospitalier Intercommunal
    Poissy, France
    Recruiting
    • Sophie COUDERC · Contact
    • Sophie COUDERC · Principal investigator
  • Centre Hospitalier René Dubos
    Pontoise, France
    Recruiting
    • Amine YANGUI · Contact
    • Amine YANGUI · Principal investigator
  • Centre Hospitalier Léon Binet
    Provins, France
    Recruiting
    • Mohamed ABDELHADI · Contact
    • Mohamed ABDELHADI · Principal investigator
  • Hôpital Laennec
    Quimper, France
    Recruiting
    • Pascal PERFEZOU · Contact
    • Pascal PERFEZOU · Principal investigator
  • CHR American Memorial Hospital
    Reims, France
    Recruiting
    • Claire PLUCHART · Contact
    • Claire PLUCHART · Principal investigator
  • CHU Pontchaillou
    Rennes, France
    Recruiting
    • Cedric ARVIEUX · Contact
    • Cedric ARVIEUX · Principal investigator
  • Hôpital Charles Nicolle
    Rouen, France
    Recruiting
    • Didier PINQUIER · Contact
    • Didier PINQUIER · Principal investigator
  • Centre Hopsitalier Yves Le Foll
    Saint Brieuc, France
    Recruiting
    • Corinne DANIEL · Contact
    • Corinne DANIEL · Principal investigator
  • Hôpital Bellevue
    Saint Etienne, France
    Recruiting
    • Kareen BILLEMAZ · Contact
    • Kareen BILLEMAZ · Principal investigator
  • Centre hospitalier
    Saint Julien, France
    Recruiting
    • Emilie PIET · Contact
    • Emilie PIET · Principal investigator
  • Centre Hospitalier de Saint Nazaire-Cité Sanitaire
    Saint Nazaire, France
    Recruiting
    • Christophe Michaud · Contact
    • Christophe Michaud · Principal investigator
  • Hôpital de Saint-Martin
    Saint-Martin, France
    Recruiting
    • Cyril CLAVEL · Contact
    • Cyril CLAVEL · Principal investigator
  • Hôpital Font Pré
    Toulon, France
    Recruiting
    • Gilles HITTINGER · Contact
    • Gilles HITTINGER · Principal investigator
  • CHRU de Tours
    Tours, France
    Recruiting
    • Louis BERNARD · Contact
    • Louis BERNARD · Principal investigator
  • Centre Hospitalier Bretagne Atlantique
    Vannes, France
    Recruiting
    • Yves POINSIGNON · Contact
    • Yves POINSIGNON · Principal investigator
  • Centre Hospitalier
    Vernon, France
    Recruiting
    • Mahfoud ROUHA · Contact
    • Mahfoud ROUHA · Principal investigator
  • Centre Hospitalier Intercommunal
    Villeneuve Saint Georges, France
    Recruiting
    • Anne CHACE · Contact
    • Anne CHACE · Principal investigator
  • CHG de Cayenne
    Cayenne, French Guiana
    Recruiting
    • Narcisse ELENGA · Contact
    • Narcisse ELENGA · Principal investigator
  • CHU Pointe à Pitre, Les Abymes
    Pointe à Pitre, Guadeloupe
    Recruiting
    • Blandine MUANZA · Contact
    • Blandine MUANZA · Principal investigator
  • Hôpital Victor Fouche
    Fort de France, Martinique
    Recruiting
    • Yves HATCHUEL · Contact
    • Yves HATCHUEL · Principal investigator
08

References and documents

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. PubMed 26197844 ↗
  • 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. PubMed 25053719 ↗
  • 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. PubMed 24781315 ↗
  • 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. PubMed 23791563 ↗
  • 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. PubMed 23728147 ↗
  • 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. PubMed 23079802 ↗
  • 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. PubMed 22130651 ↗
  • 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. PubMed 21730243 ↗
  • 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. PubMed 22460969 ↗
  • 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. PubMed 20070234 ↗
  • 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. PubMed 19424054 ↗
  • 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. PubMed 18986640 ↗
  • 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. PubMed 18614874 ↗
  • 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]. PubMed 18832880 ↗
  • 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. PubMed 18097232 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2005, a primary completion of Mar 2023 and a completion of Mar 2023. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 20, 2016
First posted
Oct 11, 2017
Start
Jun 2005
Primary completionEst.
Mar 2023
CompletionEst.
Mar 2023
Last update
Apr 30, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 30, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03306251
Responsible party
Sponsor
First posted
Oct 11, 2017
Start date
Jun 2005
Primary completion
Mar 2023 (estimated)
Completion
Mar 2023 (estimated)
Last update
Apr 30, 2021

Study contacts

Josiane WARSZAWSKI
Contact
josiane.warszawski@inserm.fr
Maud BROSSARD
Contact
maud.brossard@inserm.fr
Josiane WARSZAWSKI
principal investigator · CESP INSERM U1018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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