Prospective Observational Cohort Study on Mother to Child Transmission HIV1/HIV2 and Prevention

Mother to Child Transmission of HIV Clinical Trial

— EPF  

Official title:

ANRS CO1 EPF Prospective Observational Cohort Study on Mother-to-child Transmission HIV1 and/or HIV2 and Prevention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03235310
• Other study ID #: ANRS-CO1-EPF
• Status: Recruiting
• Start date: July 1997
• Est. completion date: March 2023

Study information

• Verified date: April 2021
• Source: ANRS, Emerging Infectious Diseases
• Contact: Josiane Warszawski
• Phone: 01 49 59 53 05
• Email: josiane.warszawski[@]inserm.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18200
• 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:

-

Related Conditions & MeSH terms

• Mother to Child Transmission of HIV

Locations

Country	Name	City	State
France	Centre Hospitalier Victor Dupuy	Argenteuil
France	Hôpital Jean Verdier	Bondy
France	Hôpital Antoine Béclère	Clamart
France	Hôpital de Beaujon	Clichy
France	Hôpital Louis Mourrier	Colombes
France	Centre Hospitalier Sud-Francilien	Corbeil-Essonnes
France	Centre Hospitalier Intercommunal	Creteil
France	Hôpital Bicêtre	Le Kremlin Bicetre
France	CHR Jeanne de Flandres	Lille
France	Hôpital de La Croix Rousse	Lyon
France	Hôpital Edouard Herriot	Lyon
France	Hôpital Femme Mère Enfant	Lyon
France	Hôpital de la conception	Marseille
France	CHR Arnaud de Villeneuve	Montpellier
France	Centre Hospitalier Intercommunal	Montreuil
France	Hôtel Dieu	Nantes
France	CHU Hôpital de l'Archet II	Nice
France	Groupe Hospitalier Cochin Tarnier Port-Royal	Paris
France	Groupe Hospitalier Necker	Paris
France	Groupe Hospitalier Pitié Salpêtrière	Paris
France	Hôpital Bichat- Claude Bernard	Paris
France	Hôpital Lariboisière	Paris
France	Hôpital Robert Debré	Paris
France	Hôpital Tenon	Paris
France	Hôpital Trousseau	Paris
France	Centre Hospitalier Général- Hôpital Delafontaine	Saint-denis
France	Hôpital Civil / Hôpital de Haute Pierre	Strasbourg
France	CHU Paule de Viguier	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
French National Agency for Research on AIDS and Viral Hepatitis

Country where clinical trial is conducted

France, 

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, 1 month, 3 months, 6 months, 12 months and 18-24 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 (Number of cases of preeclampsia, Number of cases of cholestasis, CDC stage)	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
Secondary	Risk of mother-to-child transmission of VHC, VHB and CMV co-infections	Hepatitis B serology positive, Hepatitis C serology positive, presence of CMV in the urine	At birth, 6 months, 12 months and 18-24 months