- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03235310
Prospective Observational Cohort Study on Mother to Child Transmission HIV1/HIV2 and Prevention (EPF)
ANRS CO1 EPF Prospective Observational Cohort Study on Mother-to-child Transmission HIV1 and/or HIV2 and Prevention
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Josiane Warszawski
- Phone Number: 01 49 59 53 05
- Email: josiane.warszawski@inserm.fr
Study Contact Backup
- Name: Maud BROSSARD
- Phone Number: 01 49 59 53 13
- Email: maud.brossard@inserm.fr
Study Locations
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Argenteuil, France
- Recruiting
- Centre Hospitalier Victor Dupuy
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Contact:
- Philippe GENET
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Principal Investigator:
- Philippe GENET
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Sub-Investigator:
- Philippe BRAULT
-
Bondy, France
- Recruiting
- Hôpital Jean Verdier
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Contact:
- Eric LACHASSINE
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Principal Investigator:
- Eric LACHASSINE
-
Sub-Investigator:
- Amélie BENBARA
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Sub-Investigator:
- Vincent JEANTILS
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Clamart, France
- Recruiting
- Hôpital Antoine Béclère
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Contact:
- Véronique CHAMBRIN
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Principal Investigator:
- Véronique CHAMBRIN
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Principal Investigator:
- Laure CLECH
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Clichy, France
- Recruiting
- Hôpital de Beaujon
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Contact:
- Pierre-François CECCALDI
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Principal Investigator:
- Pierre-François CECCALDI
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Colombes, France
- Recruiting
- Hopital Louis Mourrier
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Contact:
- Catherine CRENN-HEBERT
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Principal Investigator:
- Catherine CRENN-HEBERT
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Sub-Investigator:
- Laurent MANDELBROT
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Sub-Investigator:
- Corinne FLOCH TUDAL
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Corbeil-Essonnes, France
- Recruiting
- Centre Hospitalier Sud-Francilien
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Contact:
- Amélie CHABROL
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Principal Investigator:
- Amélie CHABROL
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Sub-Investigator:
- Michelle GRANIER
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Creteil, France
- Recruiting
- Centre Hospitalier Intercommunal
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Principal Investigator:
- Valérie Garrait
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Contact:
- Valérie GARRAIT
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Sub-Investigator:
- Solène LEVET
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Sub-Investigator:
- Mariem BRIKA
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Le Kremlin Bicetre, France
- Recruiting
- Hopital Bicetre
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Contact:
- Delphine PERETTI
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Principal Investigator:
- Delphine PERETTI
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Sub-Investigator:
- Claire COLMANT
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Sub-Investigator:
- Corinne FOURCADE
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Lille, France
- Recruiting
- CHR Jeanne de Flandres
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Contact:
- Yamina HAMMOU
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Principal Investigator:
- Yamina HAMMOU
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Lyon, France
- Recruiting
- Hopital de la Croix Rousse
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Contact:
- Laurent COTTE
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Principal Investigator:
- Laurent COTTE
-
Sub-Investigator:
- Jean-Marc LABAUNE
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Lyon, France
- Recruiting
- Hôpital Edouard Herriot
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Contact:
- Djamila MAKHLOUFI
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Principal Investigator:
- Djamila MAKHLOUFI
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Lyon, France
- Recruiting
- Hopital Femme Mère Enfant
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Principal Investigator:
- Jérôme MASSARDIER
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Sub-Investigator:
- Hélène GAUTHIER-MOULINIER
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Marseille, France
- Recruiting
- Hôpital de la Conception
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Contact:
- Ludovic CRAVELLO
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Principal Investigator:
- Ludovic CRAVELLO
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Montpellier, France
- Recruiting
- CHR Arnaud de Villeneuve
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Contact:
- Emmanuelle VINTEJOUX
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Principal Investigator:
- Emmanuelle VINTEJOUX
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Sub-Investigator:
- Muriel LALANDE
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Montreuil, France
- Recruiting
- Centre Hospitalier Intercommunal
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Contact:
- Brigitte HELLER - ROUSSIN
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Principal Investigator:
- Brigitte HELLER - ROUSSIN
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Sub-Investigator:
- Cécile WINTER
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Nantes, France
- Recruiting
- Hotel Dieu
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Contact:
- Cécile BRUNET
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Principal Investigator:
- Cécile BRUNET
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Sub-Investigator:
- Véronique RELIQUET
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Sub-Investigator:
- Norbert WINER
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Nice, France
- Recruiting
- CHU Hôpital de l'Archet II
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Contact:
- André BONGAIN
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Principal Investigator:
- André BONGAIN
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Sub-Investigator:
- Fabrice MONPOUX
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Paris, France
- Recruiting
- Hôpital Trousseau
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Contact:
- Catherine DOLLFUS
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Principal Investigator:
- Catherine DOLLFUS
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Paris, France
- Recruiting
- Hôpital Robert Debré
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Contact:
- Constance BORIE
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Principal Investigator:
- Constance BORIE
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Sub-Investigator:
- Albert FAYE
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Paris, France
- Recruiting
- Hôpital Tenon
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Contact:
- Lise SELLERET
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Principal Investigator:
- Lise SELLERET
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Sub-Investigator:
- François HERVE
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Paris, France
- Recruiting
- Hopital Lariboisiere
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Contact:
- Elodie GUESDON
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Sub-Investigator:
- Nicole CIRARU-VIGNERON
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Principal Investigator:
- Elodie GUESDON
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Sub-Investigator:
- Anne COURSOL
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Paris, France
- Recruiting
- Groupe Hospitalier Pitié Salpétrière
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Contact:
- Roland TUBIANA
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Principal Investigator:
- Roland TUBIANA
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Sub-Investigator:
- Marc DOMMERGUES
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Sub-Investigator:
- Frédérique QUETIN
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Paris, France
- Recruiting
- Groupe Hospitalier Cochin Tarnier Port-Royal
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Contact:
- Emmanuelle PANNIER
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Principal Investigator:
- Emmanuelle PANNIER
-
Sub-Investigator:
- Dominique SALMON CERON
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Sub-Investigator:
- Valérie MARCOU
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Paris, France
- Recruiting
- Groupe Hospitalier Necker
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Contact:
- Marine DRIESSEN
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Principal Investigator:
- Marine DRIESSEN
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Sub-Investigator:
- Stéphane BLANCHE
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Paris, France
- Recruiting
- Hôpital Bichat- Claude Bernard
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Principal Investigator:
- Jade Ghosn
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Contact:
- Jade GHOSN
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Sub-Investigator:
- Agnès BOURGEOIS-MOINE
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Saint-denis, France
- Recruiting
- Centre Hospitalier Général- Hôpital Delafontaine
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Contact:
- Pascal BOLOT
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Principal Investigator:
- Pascal BOLOT
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Sub-Investigator:
- Amel MAHDHI
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Strasbourg, France
- Recruiting
- Hôpital Civil / Hôpital de Haute Pierre
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Contact:
- Maria Luisa PARTISANI
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Principal Investigator:
- Maria Luisa PARTISANI
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Sub-Investigator:
- Michelle WEIL
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Toulouse, France
- Recruiting
- CHU Paule de Viguier
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Contact:
- Pierre DELOBEL
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Principal Investigator:
- Pierre DELOBEL
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Sub-Investigator:
- Noémie BIEZUNSKI
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- pregnant women >= 18 years
- infected with HIV1 and/or HIV2
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
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
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
|
At birth, 1 month, 3 months, 6 months, 12 months and 18-24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immuno-virological response during pregnancy
Time Frame: At inclusion up to childbirth
|
HIV ARN <50c/mL, CD4 cells count>500 cells/mL
|
At inclusion up to childbirth
|
Impact of different kind of MTCT prophylaxis on childbirth
Time Frame: At delivery
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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
Time Frame: At childbirth, 1 month, 3 months, 6 months, 12 months and 18-24 months
|
Clinical abnormalities (occurrence of adverse events)
|
At childbirth, 1 month, 3 months, 6 months, 12 months and 18-24 months
|
Tolerance and toxicity of different kind of MTCT prophylaxis during pregnancy
Time Frame: At inclusion up to childbirth
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incidence of pathologies during pregnancy (Number of cases of preeclampsia, Number of cases of cholestasis, CDC stage)
|
At inclusion up to childbirth
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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
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Hepatitis B serology positive, Hepatitis C serology positive, presence of CMV in the urine
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At birth, 6 months, 12 months and 18-24 months
|
Collaborators and Investigators
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
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ANRS-CO1-EPF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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