Clinical trial NCT03306251: National Cohort of Children Born to HIV-positive Mothers
Official title: ANRS CO11 : National Cohort of Children Born to HIV-positive Mothers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mother to Child Transmission of HIV
Keywords: HIV
Pregnancy
Prevention of mother-to-child transmission
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
First posted: 2017-10-11
Enrollment: 5200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* guardianship or judicial or administrative detention

Primary outcomes:
measure: Efficacy of PMTCT strategies by measuring rate of mother to child transmission of HIV
timeFrame: At birth up to 24 months
Secondary outcomes:
measure: Immuno-virological response during pregnancy
timeFrame: At inclusion up to childbirth
measure: Tolerance and toxicity of different kind of MTCT prophylaxis during pregnancy
timeFrame: At inclusion up to childbirth
measure: Impact of different kind of MTCT prophylaxis on childbirth
timeFrame: At delivery
measure: Impact of different kind of MTCT prophylaxis during pregnancy on uninfected children
timeFrame: At childbirth, 1 month, 3 months, 6 months, 12 months and 18-24 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Hôpital Nord
city: Angers
country: France
facility: Centre Hospitalier Universitaire
city: Annecy
country: France
facility: Centre Hosipitalier
city: Aulnay
country: France
facility: Centre Hospitalier Robert Ballanger
city: Bastia
country: France
facility: Centre Hospitalier Général de Bastia
city: Bayonne
country: France
facility: Centre Hospitalier de la Côte Basque
city: Besançon
country: France
facility: CHRU Saint Jacques
city: Bordeaux
country: France
facility: Groupe Hospitalier Pellegrin
city: Brest
country: France
facility: Centre Hospitalier Régional Universitaire de Brest
city: Béziers
country: France
facility: Centre hospitalier de Béziers
city: Caen
country: France
facility: CHRU Clemenceau
city: Chalon sur Saone
country: France
facility: Centre Hospitalier William Morey
city: Creil
country: France
facility: Centre Hospitalier Général
city: Dijon
country: France
facility: CHRU de Dijon
city: Evreux
country: France
facility: Centre Hospitalier Général
city: Fontainebleau
country: France
facility: Centre Hospitalier Général
city: La Roche sur Yon
country: France
facility: Centre Hospitalier Les Oudayries
city: Lagny sur Marne
country: France
facility: Centre Hospitalier de Lagny
city: Le Chesnay
country: France
facility: Hôpital André Mignot, Versailles
city: Limoges
country: France
facility: Centre Hospitalier Universitaire
city: Longjumeau
country: France
facility: Centre Hospitalier Général
city: Lorient
country: France
facility: Centre Hospitalier Bretagne Sud
city: Mantes la Jolie
country: France
facility: Centre Hospitalier François Quesnay
city: Maux
country: France
facility: Centre Hospitalier de Meaux
city: Melun
country: France
facility: Centre Hospitalier Marc Jacquet
city: Montfermeil
country: France
facility: Centre Hospitalier Intercommunal
city: Nancy
country: France
facility: CHU Nancy
city: Nîmes
country: France
facility: CHU Caremeau
city: Orléans
country: France
facility: Centre Hospitalier Régional
city: Orsay
country: France
facility: Centre Hospitalier Général
city: Paris
country: France
facility: Bon secours-Saint Joseph
city: Perpignan
country: France
facility: CHG Maréchal Joffre
city: Poissy
country: France
facility: Centre Hospitalier Intercommunal
city: Pontoise
country: France
facility: Centre Hospitalier René Dubos
city: Provins
country: France
facility: Centre Hospitalier Léon Binet
city: Quimper
country: France
facility: Hôpital Laennec
city: Reims
country: France
facility: CHR American Memorial Hospital
city: Rennes
country: France
facility: CHU Pontchaillou
city: Rouen
country: France
facility: Hôpital Charles Nicolle
city: Saint Brieuc
country: France
facility: Centre Hopsitalier Yves Le Foll
city: Saint Etienne
country: France
facility: Hôpital Bellevue
city: Saint Julien
country: France
facility: Centre hospitalier
city: Saint Nazaire
country: France
facility: Centre Hospitalier de Saint Nazaire-Cité Sanitaire
city: Saint-Martin
country: France
facility: Hôpital de Saint-Martin
city: Toulon
country: France
facility: Hôpital Font Pré
city: Tours
country: France
facility: CHRU de Tours
city: Vannes
country: France
facility: Centre Hospitalier Bretagne Atlantique
city: Vernon
country: France
facility: Centre Hospitalier
city: Villeneuve Saint Georges
country: France
facility: Centre Hospitalier Intercommunal
city: Cayenne
country: French Guiana
facility: CHG de Cayenne
city: Pointe à Pitre
country: Guadeloupe
facility: CHU Pointe à Pitre, Les Abymes
city: Fort de France
country: Martinique
facility: Hôpital Victor Fouche
Study officials:
affiliation: CESP INSERM U1018
name: Josiane WARSZAWSKI
role: PRINCIPAL_INVESTIGATOR
References:
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