Mother to Child Transmission of HIVEPFNCT03306251
National Cohort of Children Born to HIV-positive Mothers
An observational study of Mother to Child Transmission of HIV, run by ANRS, Emerging Infectious Diseases at 52 sites in 4 countries.
Trial 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. 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
- 5,200 participants
- Where
- 52 sitesin 4 countries
- Study dates
- Jun 2005to 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 obstetrical sites (15 sites in Paris area, 35 in mainland France and 4 in the DOM)
Who may be able to join
- pregnant women >= 18 years
- infected with HIV1 and/or HIV2
Who cannot join
- guardianship or judicial or administrative detention
Trial locations and contacts
52 sites in 4 countries.
Josiane WARSZAWSKI contact
Maud BROSSARD contact
52 sites in 4 countries
France49 sites, 49 recruiting
- Recruiting
CHU Hôpital Nord
Amiens
Jean-Luc SCHMIT
Jean-Luc SCHMIT
- Recruiting
Centre Hospitalier Universitaire
Angers
Pascale FIALAIRE
Pascale FIALAIRE
- Recruiting
Centre Hosipitalier
Annecy
Virginie Vitrat
Virginie Vitrat
- Recruiting
Centre Hospitalier Robert Ballanger
Aulnay
Marie-Anne BOULDOUYRE
- Recruiting
Centre Hospitalier Général de Bastia
Bastia
Alice Moulin
Alice Moulin
- Recruiting
Centre Hospitalier de la Côte Basque
Bayonne
Claudine CAYLA
Claudine CAYLA
- Recruiting
CHRU Saint Jacques
Besançon
Catherine CHIROUZE
Catherine CHIROUZE
- Recruiting
Centre hospitalier de Béziers
Béziers
Gilles PALENZUELA
Gilles PALENZUELA
- Recruiting
Groupe Hospitalier Pellegrin
Bordeaux
Christophe Elleau
Christophe Elleau
- Recruiting
Centre Hospitalier Régional Universitaire de Brest
Brest
Séverine ANSART
Séverine ANSART
- Recruiting
CHRU Clemenceau
Caen
Jacques BROUARD
Jacques BROUARD
- Recruiting
Centre Hospitalier William Morey
Chalon-sur-Saône
Sandrine Anne MARTHA
Sandrine Anne MARTHA
- Recruiting
Centre Hospitalier Général
Creil
Bénédicte Carpentier
Bénédicte Carpentier
- Recruiting
CHRU de Dijon
Dijon
Claire BRIANDET
Claire BRIANDET
- Recruiting
Centre Hospitalier Général
Évreux
Johnson AMA
Johnson AMA
- Recruiting
Centre Hospitalier Général
Fontainebleau
Corinne ROUTIER
Corinne ROUTIER
- Recruiting
Centre Hospitalier Les Oudayries
La Roche-sur-Yon
Thomas GUIMARD
Thomas GUIMARD
- Recruiting
Centre Hospitalier de Lagny
Lagny-sur-Marne
Armand CHALVON-DEMERSAY
Armand CHALVON-DEMERSAY
- Recruiting
Hôpital André Mignot, Versailles
Le Chesnay
Véronique HENTGEN
Véronique HENTGEN
- Recruiting
Centre Hospitalier Universitaire
Limoges
Claire GENET
Claire GENET
- Recruiting
Centre Hospitalier Général
Longjumeau
Hervé SEAUME
Hervé SEAUME
- Recruiting
Centre Hospitalier Bretagne Sud
Lorient
Mathilde Niault
Mathilde Niault
- Recruiting
Centre Hospitalier François Quesnay
Mantes-la-Jolie
Ahmed JABBAR
Ahmed JABBAR
- Recruiting
Centre Hospitalier de Meaux
Maux
Leila KARAOUI
Leila KARAOUI
- Recruiting
Centre Hospitalier Marc Jacquet
Melun
Isolde PAULY-RAVELLY
- Recruiting
Centre Hospitalier Intercommunal
Montfermeil
Marion Dehlinger-Paul
Marion Dehlinger-Paul
- Recruiting
CHU Nancy
Nancy
Claire HUBERT
Claire HUBERT
- Recruiting
CHU Caremeau
Nîmes
Joëlle DENDALE-NGUYEN
Joëlle DENDALE-NGUYEN
- Recruiting
Centre Hospitalier Régional
Orléans
Evelyne WERNER
Evelyne WERNER
- Recruiting
Centre Hospitalier Général
Orsay
DE GENNES
DE GENNES
- Recruiting
Bon secours-Saint Joseph
Paris
Marion Dehlinger-Paul
Marion Dehlinger-Paul
- Recruiting
CHG Maréchal Joffre
Perpignan
Marie MEDUS
Marie MEDUS
- Recruiting
Centre Hospitalier Intercommunal
Poissy
Sophie COUDERC
Sophie COUDERC
- Recruiting
Centre Hospitalier René Dubos
Pontoise
Amine YANGUI
Amine YANGUI
- Recruiting
Centre Hospitalier Léon Binet
Provins
Mohamed ABDELHADI
Mohamed ABDELHADI
- Recruiting
Hôpital Laennec
Quimper
Pascal PERFEZOU
Pascal PERFEZOU
- Recruiting
CHR American Memorial Hospital
Reims
Claire PLUCHART
Claire PLUCHART
- Recruiting
CHU Pontchaillou
Rennes
Cedric ARVIEUX
Cedric ARVIEUX
- Recruiting
Hôpital Charles Nicolle
Rouen
Didier PINQUIER
Didier PINQUIER
- Recruiting
Centre Hopsitalier Yves Le Foll
Saint-Brieuc
Corinne DANIEL
Corinne DANIEL
- Recruiting
Hôpital Bellevue
Saint-Etienne
Kareen BILLEMAZ
Kareen BILLEMAZ
- Recruiting
Centre hospitalier
Saint-Julien
Emilie PIET
Emilie PIET
- Recruiting
Hôpital de Saint-Martin
Saint-Martin
Cyril CLAVEL
Cyril CLAVEL
- Recruiting
Centre Hospitalier de Saint Nazaire-Cité Sanitaire
Saint-Nazaire
Christophe Michaud
Christophe Michaud
- Recruiting
Hôpital Font Pré
Toulon
Gilles HITTINGER
Gilles HITTINGER
- Recruiting
CHRU de Tours
Tours
Louis BERNARD
Louis BERNARD
- Recruiting
Centre Hospitalier Bretagne Atlantique
Vannes
Yves POINSIGNON
Yves POINSIGNON
- Recruiting
Centre Hospitalier
Vernon
Mahfoud ROUHA
Mahfoud ROUHA
- Recruiting
Centre Hospitalier Intercommunal
Villeneuve-Saint-Georges
Anne CHACE
Anne CHACE
French Guiana1 site, 1 recruiting
- Recruiting
CHG de Cayenne
Cayenne
Narcisse ELENGA
Narcisse ELENGA
Guadeloupe1 site, 1 recruiting
- Recruiting
CHU Pointe à Pitre, Les Abymes
Pointe-à-Pitre
Blandine MUANZA
Blandine MUANZA
Martinique1 site, 1 recruiting
- Recruiting
Hôpital Victor Fouche
Fort-de-France
Yves HATCHUEL
Yves HATCHUEL
About this study
Official title: ANRS CO11 : National Cohort of Children Born to HIV-positive Mothers
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.
Read the 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.
- Conditions
- Mother to Child Transmission of HIV
- 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.
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 up to 24 months
Secondary outcomes (4)
Immuno-virological response during pregnancy
HIV ARN <50c/mL, CD4 cells count>500 cells/mL
Measured: At inclusion up to childbirth
Tolerance and toxicity of different kind of MTCT prophylaxis during pregnancy
incidence of pathologies during pregnancy
Measured: At inclusion up to childbirth
Impact of different kind of MTCT prophylaxis on childbirth
Childbirth mode (Number of emergency Caesarean section, Number of planned caesarean section)
Measured: At delivery
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study startJun 2005
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Mother to Child Transmission of HIVStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 5,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Josiane WARSZAWSKI, Principal investigator, CESP INSERM U1018
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306251
- Sponsor's protocol ID
- ANRS-CO11-EPF
- Acronym
- EPF
- Status last verified
- Apr 2021
- First submitted
- 20 Sep 2016
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- 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 26197844Taron-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 25053719Sibiude 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 24781315Briand 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 23791563Briand 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 23728147Rachas 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 23079802Jasseron 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 22130651Simon 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 21730243Sibiude 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 22460969Tubiana 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 20070234Briand 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 19424054Mandelbrot 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 18986640Jasseron 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 18614874Benhammou 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 18832880Warszawski 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ANRS CO11 : National Cohort of Children Born to HIV-positive Mothers
- ClinicalTrials.gov ID
- NCT03306251
- Acronym / sponsor ID
- EPF / ANRS-CO11-EPF
- Conditions
- Mother to Child Transmission of HIV
- Keywords
- HIV, Pregnancy, Prevention of mother-to-child transmission
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,200 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- Jun 2005
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 11 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (2 listed)
- pregnant women >= 18 years
- infected with HIV1 and/or HIV2
Key exclusion criteria (1 listed)
- guardianship or judicial or administrative detention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Efficacy of PMTCT strategies by measuring rate of mother to child transmission of HIV
Time frame: At birth up to 24 months
Number of infected children (HIV RNA >50c/mL or Positive serology) reported on the total number of children
4 secondary outcomes
Immuno-virological response during pregnancy
Time frame: At inclusion up to childbirth
Tolerance and toxicity of different kind of MTCT prophylaxis during pregnancy
Time frame: At inclusion up to childbirth
Impact of different kind of MTCT prophylaxis on childbirth
Time frame: At delivery
Impact of different kind of MTCT prophylaxis during pregnancy on uninfected children
Time frame: At childbirth, 1 month, 3 months, 6 months, 12 months and 18-24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Results publication: PubMed 26197844Mandelbrot 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.
- Results publication: PubMed 25053719Taron-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.
- Results publication: PubMed 24781315Sibiude 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.
- Results publication: PubMed 23791563Briand 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.
- Results publication: PubMed 23728147Briand 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.
- Results publication: PubMed 23079802Rachas 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.
- Results publication: PubMed 22130651Jasseron 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.
- Results publication: PubMed 21730243Simon 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.
- Results publication: PubMed 22460969Sibiude 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.
- Results publication: PubMed 20070234Tubiana 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.
- Results publication: PubMed 19424054Briand 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.
- Results publication: PubMed 18986640Mandelbrot 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josiane WARSZAWSKI contact
Maud BROSSARD contact
Josiane WARSZAWSKI principal investigator
CESP INSERM U1018
52 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mother to Child Transmission of HIV, run by ANRS, Emerging Infectious Diseases at 52 sites in 4 countries.
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 30 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 52 sites in France, French Guiana, Guadeloupe, Martinique. 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 (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 up to 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 NCT03306251, 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 30 Apr 2021.