Clinical trial NCT03235310: Prospective Observational Cohort Study on Mother to Child Transmission HIV1/HIV2 and Prevention
Official title: ANRS CO1 EPF Prospective Observational Cohort Study on Mother-to-child Transmission HIV1 and/or HIV2 and Prevention
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: 2017-08-01
Enrollment: 18200
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 the largest obstetrical sites (17 in Paris area and 8 elsewhere in mainland France)

Brief summary: The purpose of this study is to describe over time the rate of mother to child transmission of HIV and its prevention (PMTCT), to identify risk factors for transmission and to evaluate the safety of PMTCT strategies on outcome of pregnancy and in children not infected with HIV

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: Efficacy of PMTCT strategies by measuring rate of mother to child transmission of HIV
timeFrame: At birth, 1 month, 3 months, 6 months, 12 months and 18-24 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
measure: Risk of mother-to-child transmission of VHC, VHB and CMV co-infections
timeFrame: At birth, 6 months, 12 months and 18-24 months
Other outcomes:
Locations:
city: Argenteuil
country: France
facility: Centre Hospitalier Victor Dupuy
city: Bondy
country: France
facility: Hôpital Jean Verdier
city: Clamart
country: France
facility: Hôpital Antoine Béclère
city: Clichy
country: France
facility: Hôpital de Beaujon
city: Colombes
country: France
facility: Hôpital Louis Mourrier
city: Corbeil-Essonnes
country: France
facility: Centre Hospitalier Sud-Francilien
city: Creteil
country: France
facility: Centre Hospitalier Intercommunal
city: Le Kremlin Bicetre
country: France
facility: Hôpital Bicêtre
city: Lille
country: France
facility: CHR Jeanne de Flandres
city: Lyon
country: France
facility: Hôpital de La Croix Rousse
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Lyon
country: France
facility: Hôpital Femme Mère Enfant
city: Marseille
country: France
facility: Hôpital de la conception
city: Montpellier
country: France
facility: CHR Arnaud de Villeneuve
city: Montreuil
country: France
facility: Centre Hospitalier Intercommunal
city: Nantes
country: France
facility: Hôtel Dieu
city: Nice
country: France
facility: CHU Hôpital de l'Archet II
city: Paris
country: France
facility: Groupe Hospitalier Cochin Tarnier Port-Royal
city: Paris
country: France
facility: Groupe Hospitalier Necker
city: Paris
country: France
facility: Groupe Hospitalier Pitié Salpêtrière
city: Paris
country: France
facility: Hôpital Bichat- Claude Bernard
city: Paris
country: France
facility: Hôpital Lariboisière
city: Paris
country: France
facility: Hôpital Robert Debré
city: Paris
country: France
facility: Hôpital Tenon
city: Paris
country: France
facility: Hôpital Trousseau
city: Saint-denis
country: France
facility: Centre Hospitalier Général- Hôpital Delafontaine
city: Strasbourg
country: France
facility: Hôpital Civil / Hôpital de Haute Pierre
city: Toulouse
country: France
facility: CHU Paule de Viguier
Study officials:
affiliation: CESP INSERM U1018
name: Josiane Warszawski
role: PRINCIPAL_INVESTIGATOR
References:
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