National Cohort of Children Born to HIV-positive Mothers

Mother to Child Transmission of HIV Clinical Trial

— EPF  

Official title:

ANRS CO11 : National Cohort of Children Born to HIV-positive Mothers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03306251
• Other study ID #: ANRS-CO11-EPF
• Status: Recruiting
• Start date: June 2005
• Est. completion date: March 2023

Study information

• Verified date: April 2021
• Source: ANRS, Emerging Infectious Diseases
• Contact: Josiane WARSZAWSKI
• Email: josiane.warszawski[@]inserm.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5200
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• guardianship or judicial or administrative detention

Related Conditions & MeSH terms

• HIV Seropositivity
• Mother to Child Transmission of HIV

Locations

Country	Name	City	State
France	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 Saone
France	Centre Hospitalier Général	Creil
France	CHRU de Dijon	Dijon
France	Centre Hospitalier Général	Evreux
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	Centre Hospitalier de Saint Nazaire-Cité Sanitaire	Saint Nazaire
France	Hôpital de Saint-Martin	Saint-Martin
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
French Guiana	CHG de Cayenne	Cayenne
Guadeloupe	CHU Pointe à Pitre, Les Abymes	Pointe à Pitre
Martinique	Hôpital Victor Fouche	Fort de France

Sponsors (1)

Lead Sponsor	Collaborator
ANRS, Emerging Infectious Diseases

Countries where clinical trial is conducted

France,  French Guiana,  Guadeloupe,  Martinique, 

References & Publications (15)

Benhammou V, Warszawski J, Bellec S, Doz F, André N, Lacour B, Levine M, Bavoux F, Tubiana R, Mandelbrot L, Clavel J, Blanche S; ANRS-Enquête Périnatale Française. Incidence of cancer in children perinatally exposed to nucleoside reverse transcriptase inh — View Citation

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 — View Citation

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) — View Citation

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 t — View Citation

Jasseron C, Mandelbrot L, Dollfus C, Trocmé 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. AID — View Citation

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 F — View Citation

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 — View Citation

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 transmis — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

Simon A, Warszawski J, Kariyawasam D, Le Chenadec J, Benhammou V, Czernichow P, Foissac F, Laborde K, Tréluyer JM, Firtion G, Layouni I, Munzer M, Bavoux F, Polak M, Blanche S; ANRS French Perinatal Cohort Study Group. Association of prenatal and postnata — View Citation

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 o — View Citation

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 — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Immuno-virological response during pregnancy	HIV ARN <50c/mL, CD4 cells count>500 cells/mL	At inclusion up to childbirth
Secondary	Tolerance and toxicity of different kind of MTCT prophylaxis during pregnancy	incidence of pathologies during pregnancy	At inclusion up to childbirth
Secondary	Impact of different kind of MTCT prophylaxis on childbirth	Childbirth mode (Number of emergency Caesarean section, Number of planned caesarean section)	At delivery
Secondary	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