NCT03235310

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 1997

Longer than P75 for all trials

Geographic Reach
1 country

28 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1997

Completed
19.3 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2016

Completed
10 months until next milestone

First Posted

Study publicly available on registry

August 1, 2017

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

April 13, 2021

Status Verified

April 1, 2021

Enrollment Period

25.7 years

First QC Date

September 29, 2016

Last Update Submit

April 12, 2021

Conditions

Mother to Child Transmission of HIV

Keywords

HIVPregnancyPrevention of mother-to-child transmission

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Immuno-virological response during pregnancy

    At inclusion up to childbirth

  • Tolerance and toxicity of different kind of MTCT prophylaxis during pregnancy

    At inclusion up to childbirth

  • Impact of different kind of MTCT prophylaxis on childbirth

    At delivery

  • Impact of different kind of MTCT prophylaxis during pregnancy on uninfected children

    At childbirth, 1 month, 3 months, 6 months, 12 months and 18-24 months

  • Risk of mother-to-child transmission of VHC, VHB and CMV co-infections

    At birth, 6 months, 12 months and 18-24 months

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

Centre Hospitalier Victor Dupuy

Argenteuil, France

RECRUITING

Hôpital Jean Verdier

Bondy, France

RECRUITING

Hôpital Antoine Béclère

Clamart, France

RECRUITING

Hôpital de Beaujon

Clichy, France

RECRUITING

Hôpital Louis Mourrier

Colombes, France

RECRUITING

Centre Hospitalier Sud-Francilien

Corbeil-Essonnes, France

RECRUITING

Centre Hospitalier Intercommunal

Créteil, France

RECRUITING

Hôpital Bicêtre

Le Kremlin-Bicêtre, France

RECRUITING

CHR Jeanne de Flandres

Lille, France

RECRUITING

Hôpital de La Croix Rousse

Lyon, France

RECRUITING

Hôpital Edouard Herriot

Lyon, France

RECRUITING

Hôpital Femme Mère Enfant

Lyon, France

RECRUITING

Hôpital de la conception

Marseille, France

RECRUITING

CHR Arnaud de Villeneuve

Montpellier, France

RECRUITING

Centre Hospitalier Intercommunal

Montreuil, France

RECRUITING

Hôtel Dieu

Nantes, France

RECRUITING

CHU Hôpital de l'Archet II

Nice, France

RECRUITING

Groupe Hospitalier Cochin Tarnier Port-Royal

Paris, France

RECRUITING

Groupe Hospitalier Necker

Paris, France

RECRUITING

Groupe Hospitalier Pitié Salpêtrière

Paris, France

RECRUITING

Hôpital Bichat- Claude Bernard

Paris, France

RECRUITING

Hôpital Lariboisière

Paris, France

RECRUITING

Hôpital Robert Debré

Paris, France

RECRUITING

Hôpital Tenon

Paris, France

RECRUITING

Hôpital Trousseau

Paris, France

RECRUITING

Centre Hospitalier Général- Hôpital Delafontaine

Saint-Denis, France

RECRUITING

Hôpital Civil / Hôpital de Haute Pierre

Strasbourg, France

RECRUITING

CHU Paule de Viguier

Toulouse, France

RECRUITING

Related Publications (15)

  • 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.

    PMID: 26197844RESULT

  • 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.

    PMID: 25053719RESULT

  • 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.

    PMID: 24781315RESULT

  • 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.

    PMID: 23791563RESULT

  • 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.

    PMID: 23728147RESULT

  • 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.

    PMID: 23079802RESULT

  • 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.

    PMID: 22130651RESULT

  • 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.

    PMID: 21730243RESULT

  • 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.

    PMID: 22460969RESULT

  • 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.

    PMID: 20070234RESULT

  • 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.

    PMID: 19424054RESULT

  • 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.

    PMID: 18986640RESULT

  • 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.

    PMID: 18614874RESULT

  • 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.

    PMID: 18832880RESULT

  • 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.

    PMID: 18097232RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

3 mL whole blood 3mL plasma

Study Officials

  • Josiane Warszawski

    CESP INSERM U1018

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Josiane Warszawski

CONTACT

01 49 59 53 05josiane.warszawski@inserm.fr

Maud BROSSARD

CONTACT

01 49 59 53 13maud.brossard@inserm.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2016

First Posted

August 1, 2017

Study Start

July 1, 1997

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

April 13, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(28)