National Cohort of Children Born to HIV-positive Mothers
EPF
ANRS CO11 : National Cohort of Children Born to HIV-positive Mothers
1 other identifier
observational
5,200
3 countries
51
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2005
Longer than P75 for all trials
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 20, 2016
CompletedFirst Posted
Study publicly available on registry
October 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2023
CompletedApril 30, 2021
April 1, 2021
17.8 years
September 20, 2016
April 29, 2021
Conditions
Keywords
Outcome Measures
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
At birth up to 24 months
Secondary Outcomes (4)
Immuno-virological response during pregnancy
At inclusion up to childbirth
Tolerance and toxicity of different kind of MTCT prophylaxis during pregnancy
At inclusion up to childbirth
Impact of different kind of MTCT prophylaxis on childbirth
At delivery
Impact of different kind of MTCT prophylaxis during pregnancy on uninfected children
At childbirth, 1 month, 3 months, 6 months, 12 months and 18-24 months
Eligibility Criteria
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)
You may qualify if:
- pregnant women \>= 18 years
- infected with HIV1 and/or HIV2
You may not qualify if:
- guardianship or judicial or administrative detention
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (52)
CHU Hôpital Nord
Amiens, France
Centre Hospitalier Universitaire
Angers, France
Centre Hosipitalier
Annecy, France
Centre Hospitalier Robert Ballanger
Aulnay, France
Centre Hospitalier Général de Bastia
Bastia, France
Centre Hospitalier de la Côte Basque
Bayonne, France
CHRU Saint Jacques
Besançon, France
Centre hospitalier de Béziers
Béziers, France
Groupe Hospitalier Pellegrin
Bordeaux, France
Centre Hospitalier Régional Universitaire de Brest
Brest, France
CHRU Clemenceau
Caen, France
Centre Hospitalier William Morey
Chalon-sur-Saône, France
Centre Hospitalier Général
Creil, France
CHRU de Dijon
Dijon, France
Centre Hospitalier Général
Évreux, France
Centre Hospitalier Général
Fontainebleau, France
Centre Hospitalier Les Oudayries
La Roche-sur-Yon, France
Centre Hospitalier de Lagny
Lagny-sur-Marne, France
Hôpital André Mignot, Versailles
Le Chesnay, France
Centre Hospitalier Universitaire
Limoges, France
Centre Hospitalier Général
Longjumeau, France
Centre Hospitalier Bretagne Sud
Lorient, France
Centre Hospitalier François Quesnay
Mantes-la-Jolie, France
Centre Hospitalier de Meaux
Maux, France
Centre Hospitalier Marc Jacquet
Melun, France
Centre Hospitalier Intercommunal
Montfermeil, France
CHU Nancy
Nancy, France
CHU Caremeau
Nîmes, France
Centre Hospitalier Régional
Orléans, France
Centre Hospitalier Général
Orsay, France
Bon secours-Saint Joseph
Paris, France
CHG Maréchal Joffre
Perpignan, France
Centre Hospitalier Intercommunal
Poissy, France
Centre Hospitalier René Dubos
Pontoise, France
Centre Hospitalier Léon Binet
Provins, France
Hôpital Laennec
Quimper, France
CHR American Memorial Hospital
Reims, France
CHU Pontchaillou
Rennes, France
Hôpital Charles Nicolle
Rouen, France
Centre Hopsitalier Yves Le Foll
Saint-Brieuc, France
Hôpital Bellevue
Saint-Etienne, France
Centre hospitalier
Saint-Julien, France
Hôpital de Saint-Martin
Saint-Martin, France
Centre Hospitalier de Saint Nazaire-Cité Sanitaire
Saint-Nazaire, France
Hôpital Font Pré
Toulon, France
CHRU de Tours
Tours, France
Centre Hospitalier Bretagne Atlantique
Vannes, France
Centre Hospitalier
Vernon, France
Centre Hospitalier Intercommunal
Villeneuve-Saint-Georges, France
CHG de Cayenne
Cayenne, French Guiana
CHU Pointe à Pitre, Les Abymes
Pointe-à-Pitre, Guadeloupe
Hôpital Victor Fouche
Fort-de-France, Martinique
Related Publications (15)
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.
PMID: 26197844RESULTTaron-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.
PMID: 25053719RESULTSibiude 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.
PMID: 24781315RESULTBriand 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.
PMID: 23791563RESULTBriand 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.
PMID: 23728147RESULTRachas 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.
PMID: 23079802RESULTJasseron 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.
PMID: 22130651RESULTSimon 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.
PMID: 21730243RESULTSibiude 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.
PMID: 22460969RESULTTubiana 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.
PMID: 20070234RESULTBriand 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.
PMID: 19424054RESULTMandelbrot 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.
PMID: 18986640RESULTJasseron 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.
PMID: 18614874RESULTBenhammou 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.
PMID: 18832880RESULTWarszawski 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.
PMID: 18097232RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
Josiane WARSZAWSKI
CESP INSERM U1018
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2016
First Posted
October 11, 2017
Study Start
June 1, 2005
Primary Completion
March 1, 2023
Study Completion
March 1, 2023
Last Updated
April 30, 2021
Record last verified: 2021-04