National Cohort of Children Born to HIV-positive Mothers
NCT ID: NCT03306251
Last Updated: 2021-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
5200 participants
OBSERVATIONAL
2005-06-30
2023-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prospective Observational Cohort Study on Mother to Child Transmission HIV1/HIV2 and Prevention
NCT03235310
Cohort of Young Adults Infected With HIV Since Birth or During Childhood
NCT01269632
Cohort of HIV-infected Children
NCT03235258
Becoming HIV-Exposed, Uninfected Children Born to HIV-Positive Mothers Followed at Bichat Claude Bernard Hospital
NCT06666543
Pregnancy, Anti-integrase and Lymphocyte Repertoire of the Newborn
NCT04024150
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* infected with HIV1 and/or HIV2
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
ANRS, Emerging Infectious Diseases
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Josiane WARSZAWSKI
Role: PRINCIPAL_INVESTIGATOR
CESP INSERM U1018
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Jean-Luc SCHMIT
Role: primary
Pascale FIALAIRE
Role: primary
Virginie Vitrat
Role: primary
Marie-Anne BOULDOUYRE
Role: primary
Alice Moulin
Role: primary
Claudine CAYLA
Role: primary
Catherine CHIROUZE
Role: primary
Gilles PALENZUELA
Role: primary
Christophe Elleau
Role: primary
Séverine ANSART
Role: primary
Jacques BROUARD
Role: primary
Sandrine Anne MARTHA
Role: primary
Bénédicte Carpentier
Role: primary
Claire BRIANDET
Role: primary
Johnson AMA
Role: primary
Corinne ROUTIER
Role: primary
Thomas GUIMARD
Role: primary
Armand CHALVON-DEMERSAY
Role: primary
Véronique HENTGEN
Role: primary
Claire GENET
Role: primary
Hervé SEAUME
Role: primary
Mathilde Niault
Role: primary
Ahmed JABBAR
Role: primary
Leila KARAOUI
Role: primary
Isolde PAULY-RAVELLY
Role: primary
Marion Dehlinger-Paul
Role: primary
Claire HUBERT
Role: primary
Joëlle DENDALE-NGUYEN
Role: primary
Evelyne WERNER
Role: primary
DE GENNES
Role: primary
Marion Dehlinger-Paul
Role: primary
Marie MEDUS
Role: primary
Sophie COUDERC
Role: primary
Amine YANGUI
Role: primary
Mohamed ABDELHADI
Role: primary
Pascal PERFEZOU
Role: primary
Claire PLUCHART
Role: primary
Cedric ARVIEUX
Role: primary
Didier PINQUIER
Role: primary
Corinne DANIEL
Role: primary
Kareen BILLEMAZ
Role: primary
Emilie PIET
Role: primary
Cyril CLAVEL
Role: primary
Christophe Michaud
Role: primary
Gilles HITTINGER
Role: primary
Louis BERNARD
Role: primary
Yves POINSIGNON
Role: primary
Mahfoud ROUHA
Role: primary
Anne CHACE
Role: primary
Narcisse ELENGA
Role: primary
Blandine MUANZA
Role: primary
Yves HATCHUEL
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ANRS-CO11-EPF
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.