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Mother to Child Transmission of HIVEPFNCT03235310

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

An observational study of Mother to Child Transmission of HIV, run by French National Agency for Research on AIDS and Viral Hepatitis at 28 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Mother to Child Transmission of HIV
How many people
18,200 participants
Where
28 sitesFrance
Study dates
Jul 1997to Mar 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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)

Who may be able to join

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

Who cannot join

  • -

Trial locations and contacts

28 sites in 1 country.

Josiane Warszawski contact

01 49 59 53 05

josiane.warszawski@inserm.fr

Maud BROSSARD contact

01 49 59 53 13

maud.brossard@inserm.fr

28 sites in 1 country

France28 sites, 28 recruiting

  • Centre Hospitalier Victor Dupuy

    Argenteuil

    Philippe GENET

    Philippe GENET

    Recruiting

  • Hôpital Jean Verdier

    Bondy

    Eric LACHASSINE

    Eric LACHASSINE

    Recruiting

  • Hôpital Antoine Béclère

    Clamart

    Véronique CHAMBRIN

    Véronique CHAMBRIN

    Recruiting

  • Hôpital de Beaujon

    Clichy

    Pierre-François CECCALDI

    Pierre-François CECCALDI

    Recruiting

  • Hôpital Louis Mourrier

    Colombes

    Catherine CRENN-HEBERT

    Catherine CRENN-HEBERT

    Recruiting

  • Centre Hospitalier Sud-Francilien

    Corbeil-Essonnes

    Amélie CHABROL

    Amélie CHABROL

    Recruiting

  • Centre Hospitalier Intercommunal

    Créteil

    Valérie GARRAIT

    Valérie GARRAIT

    Recruiting

  • Hôpital Bicêtre

    Le Kremlin-Bicêtre

    Delphine PERETTI

    Delphine PERETTI

    Recruiting

  • CHR Jeanne de Flandres

    Lille

    Yamina HAMMOU

    Yamina HAMMOU

    Recruiting

  • Hôpital de La Croix Rousse

    Lyon

    Laurent COTTE

    Laurent COTTE

    Recruiting

  • Hôpital Edouard Herriot

    Lyon

    Djamila MAKHLOUFI

    Djamila MAKHLOUFI

    Recruiting

  • Hôpital Femme Mère Enfant

    Lyon

    Jérôme MASSARDIER

    Jérôme MASSARDIER

    Recruiting

  • Hôpital de la conception

    Marseille

    Ludovic CRAVELLO

    Ludovic CRAVELLO

    Recruiting

  • CHR Arnaud de Villeneuve

    Montpellier

    Emmanuelle VINTEJOUX

    Emmanuelle VINTEJOUX

    Recruiting

  • Centre Hospitalier Intercommunal

    Montreuil

    Brigitte HELLER - ROUSSIN

    Brigitte HELLER - ROUSSIN

    Recruiting

  • Hôtel Dieu

    Nantes

    Cécile BRUNET

    Cécile BRUNET

    Recruiting

  • CHU Hôpital de l'Archet II

    Nice

    André BONGAIN

    André BONGAIN

    Recruiting

  • Groupe Hospitalier Cochin Tarnier Port-Royal

    Paris

    Emmanuelle PANNIER

    Emmanuelle PANNIER

    Recruiting

  • Groupe Hospitalier Necker

    Paris

    Marine DRIESSEN

    Marine DRIESSEN

    Recruiting

  • Groupe Hospitalier Pitié Salpêtrière

    Paris

    Roland TUBIANA

    Roland TUBIANA

    Recruiting

  • Hôpital Bichat- Claude Bernard

    Paris

    Jade GHOSN

    Jade GHOSN

    Recruiting

  • Hôpital Lariboisière

    Paris

    Elodie GUESDON

    Nicole CIRARU-VIGNERON

    Recruiting

  • Hôpital Robert Debré

    Paris

    Constance BORIE

    Constance BORIE

    Recruiting

  • Hôpital Tenon

    Paris

    Lise SELLERET

    Lise SELLERET

    Recruiting

  • Hôpital Trousseau

    Paris

    Catherine DOLLFUS

    Catherine DOLLFUS

    Recruiting

  • Centre Hospitalier Général- Hôpital Delafontaine

    Saint-Denis

    Pascal BOLOT

    Pascal BOLOT

    Recruiting

  • Hôpital Civil / Hôpital de Haute Pierre

    Strasbourg

    Maria Luisa PARTISANI

    Maria Luisa PARTISANI

    Recruiting

  • CHU Paule de Viguier

    Toulouse

    Pierre DELOBEL

    Pierre DELOBEL

    Recruiting

Other trials in France

About this study

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

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

Read the 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.

Keywords
HIV, Pregnancy, Prevention of mother-to-child transmission

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: At birth, 1 month, 3 months, 6 months, 12 months and 18-24 months

Secondary outcomes (5)

  1. Immuno-virological response during pregnancy

    HIV ARN <50c/mL, CD4 cells count>500 cells/mL

    Measured: At inclusion up to childbirth

  2. 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)

    Measured: At inclusion up to childbirth

  3. Impact of different kind of MTCT prophylaxis on childbirth

    Childbirth mode (Number of emergency Caesarean section, Number of planned caesarean section)

    Measured: At delivery

  4. Impact of different kind of MTCT prophylaxis during pregnancy on uninfected children

    Clinical abnormalities (occurrence of adverse events)

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

  5. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2017
  2. Study startJul 1997
  3. Primary completionMar 2023 (estimated)
  4. Study completionMar 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
18,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03235310
Sponsor's protocol ID
ANRS-CO1-EPF
Acronym
EPF
Status last verified
Apr 2021
First submitted
29 Sep 2016
Last updated
13 Apr 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26197844

  • 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.

    PubMed 25053719

  • 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.

    PubMed 24781315

  • 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.

    PubMed 23791563

  • 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.

    PubMed 23728147

  • 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.

    PubMed 23079802

  • 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.

    PubMed 22130651

  • 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.

    PubMed 21730243

  • 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.

    PubMed 22460969

  • 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.

    PubMed 20070234

  • 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.

    PubMed 19424054

  • 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.

    PubMed 18986640

  • 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.

    PubMed 18614874

  • 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.

    PubMed 18832880

  • 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.

    PubMed 18097232

Questions about this trial

What is this clinical trial studying?

An observational study of Mother to Child Transmission of HIV, run by French National Agency for Research on AIDS and Viral Hepatitis at 28 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Josiane Warszawski (01 49 59 53 05, josiane.warszawski@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of PMTCT strategies by measuring rate of mother to child transmission of HIV (time frame: At birth, 1 month, 3 months, 6 months, 12 months and 18-24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03235310, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.

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