Cohort of HIV-infected Children

NCT ID: NCT03235258

Last Updated: 2021-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

812 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-07-31

Study Completion Date

2020-06-30

Brief Summary

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The purpose of this study is to describe the conditions of access to early treatment of children infected with HIV, their management on the long-term, and impact on growth, clinical and immunovirological prognosis, adherence to treatment, living conditions

Detailed Description

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The CO10 EPF paediatric cohort includes therapeutic, clinical and biological detailed questionnaires. The data are collected by the doctors every three months to 2 years and then every 6 months until to 18 years or every year by a simplified questionnaire if medical follow up continues outside of a participating site.

After 18 years of age, the patients are eligibile for the ANRS CO19-Coverte cohort.

Conditions

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Children Infected by HIV

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* HIV-infected children born to mothers included in ANRS-CO1 EPF or children under the age of 13 newly entered in care management with no prior antiretroviral therapy, whose mother was or not included in ANRS-CO1 EPF

Exclusion Criteria

* \>= 13 years
* refusal of legal representative of the child
* antiretroviral therapy started before the entry in care management
* care management for over 6 months before inclusion
Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ANRS, Emerging Infectious Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Josiane WARSZAWSKI

Role: PRINCIPAL_INVESTIGATOR

CESP INSERM U1018

Locations

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CHU Angers

Angers, , France

Site Status

CHU Hôpital Jean Minjoz

Besançon, , France

Site Status

Hôpital Jean Verdier

Bondy, , France

Site Status

Centre Hospitalier Pellegrin

Bordeaux, , France

Site Status

CHU Caen

Caen, , France

Site Status

Hôpital Antoine Béclère

Clamart, , France

Site Status

Hôpital Louis Mourier

Colombes, , France

Site Status

Centre hospitalier Francilien Sud

Corbeil-Essonnes, , France

Site Status

Hôpital Bicêtre

LE Kremlin Bicëtre, , France

Site Status

CHR Jeanne de Flandres

Lille, , France

Site Status

Institut d'Hématologie et Oncologie Pédiatrique

Lyon, , France

Site Status

CHR Arnaud de Villeneuve

Montpellier, , France

Site Status

Centre Hospitalier Intercommunal

Montreuil, , France

Site Status

CHU Nantes Hotel Dieu

Nantes, , France

Site Status

CHU Hôpital de l'Archet II

Nice, , France

Site Status

Groupe Hospitalier Cochin Tarnier Port-Royal

Paris, , France

Site Status

Groupe Hospitalier Necker

Paris, , France

Site Status

Hôpital Robert Debré

Paris, , France

Site Status

Hôpital Trousseau

Paris, , France

Site Status

Centre Hospitalier Général- Hôpital Delafontaine

Saint-Denis, , France

Site Status

Hôpital Civil

Strasbourg, , France

Site Status

CHU Paule de Viguier

Toulouse, , France

Site Status

Centre Hospitalier Général

Villeneuve-Saint-Georges, , France

Site Status

Countries

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France

References

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Frange P, Faye A, Avettand-Fenoel V, Bellaton E, Descamps D, Angin M, David A, Caillat-Zucman S, Peytavin G, Dollfus C, Le Chenadec J, Warszawski J, Rouzioux C, Saez-Cirion A; ANRS EPF-CO10 Pediatric Cohort and the ANRS EP47 VISCONTI study group. HIV-1 virological remission lasting more than 12 years after interruption of early antiretroviral therapy in a perinatally infected teenager enrolled in the French ANRS EPF-CO10 paediatric cohort: a case report. Lancet HIV. 2016 Jan;3(1):e49-54. doi: 10.1016/S2352-3018(15)00232-5. Epub 2015 Dec 9.

Reference Type RESULT
PMID: 26762993 (View on PubMed)

Aupiais C, Faye A, Le Chenadec J, Rouzioux C, Bouallag N, Laurent C, Blanche S, Dollfus C, Warszawski J; ANRS EPF-CO10 French Pediatric Cohort. Interruption of cART in clinical practice is associated with an increase in the long-term risk of subsequent immunosuppression in HIV-1-infected children. Pediatr Infect Dis J. 2014 Dec;33(12):1237-45. doi: 10.1097/INF.0000000000000450.

Reference Type RESULT
PMID: 24945880 (View on PubMed)

Sofeu CL, Warszawski J, Ateba Ndongo F, Penda IC, Tetang Ndiang S, Guemkam G, Makwet N, Owona F, Kfutwah A, Tchendjou P, Texier G, Tchuente M, Faye A, Tejiokem MC; ANRS-PEDIACAM Study Group. Low birth weight in perinatally HIV-exposed uninfected infants: observations in urban settings in Cameroon. PLoS One. 2014 Apr 3;9(4):e93554. doi: 10.1371/journal.pone.0093554. eCollection 2014.

Reference Type RESULT
PMID: 24705410 (View on PubMed)

Blanche S, Scott-Algara D, Le Chenadec J, Didier C, Montange T, Avettand-Fenoel V, Rouzioux C, Melard A, Viard JP, Dollfus C, Bouallag N, Warszawski J, Buseyne F. Naive T lymphocytes and recent thymic emigrants are associated with HIV-1 disease history in french adolescents and young adults infected in the perinatal period: the ANRS-EP38-IMMIP study. Clin Infect Dis. 2014 Feb;58(4):573-87. doi: 10.1093/cid/cit729. Epub 2013 Nov 18.

Reference Type RESULT
PMID: 24253249 (View on PubMed)

Avettand-Fenoel V, Blanche S, Le Chenadec J, Scott-Algara D, Dollfus C, Viard JP, Bouallag N, Benmebarek Y, Riviere Y, Warszawski J, Rouzioux C, Buseyne F. Relationships between HIV disease history and blood HIV-1 DNA load in perinatally infected adolescents and young adults: the ANRS-EP38-IMMIP study. J Infect Dis. 2012 May 15;205(10):1520-8. doi: 10.1093/infdis/jis233. Epub 2012 Mar 15.

Reference Type RESULT
PMID: 22427678 (View on PubMed)

Goetghebuer T, Le Chenadec J, Haelterman E, Galli L, Dollfus C, Thorne C, Judd A, Keiser O, Ramos JT, Levy J, Warszawski J; European Infant Collaboration Group. Short- and long-term immunological and virological outcome in HIV-infected infants according to the age at antiretroviral treatment initiation. Clin Infect Dis. 2012 Mar;54(6):878-81. doi: 10.1093/cid/cir950. Epub 2011 Dec 23.

Reference Type RESULT
PMID: 22198788 (View on PubMed)

Judd A; European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC) study group in EuroCoord. Early antiretroviral therapy in HIV-1-infected infants, 1996-2008: treatment response and duration of first-line regimens. AIDS. 2011 Nov 28;25(18):2279-87. doi: 10.1097/QAD.0b013e32834d614c.

Reference Type RESULT
PMID: 21971357 (View on PubMed)

Pursuing Later Treatment Options II (PLATO II) project team for the Collaboration of Observational HIV Epidemiological Research Europe (COHERE); Castro H, Judd A, Gibb DM, Butler K, Lodwick RK, van Sighem A, Ramos JT, Warsawski J, Thorne C, Noguera-Julian A, Obel N, Costagliola D, Tookey PA, Colin C, Kjaer J, Grarup J, Chene G, Phillips A. Risk of triple-class virological failure in children with HIV: a retrospective cohort study. Lancet. 2011 May 7;377(9777):1580-7. doi: 10.1016/S0140-6736(11)60208-0. Epub 2011 Apr 20.

Reference Type RESULT
PMID: 21511330 (View on PubMed)

Dollfus C, Le Chenadec J, Faye A, Blanche S, Briand N, Rouzioux C, Warszawski J. Long-term outcomes in adolescents perinatally infected with HIV-1 and followed up since birth in the French perinatal cohort (EPF/ANRS CO10). Clin Infect Dis. 2010 Jul 15;51(2):214-24. doi: 10.1086/653674.

Reference Type RESULT
PMID: 20536367 (View on PubMed)

Goetghebuer T, Haelterman E, Le Chenadec J, Dollfus C, Gibb D, Judd A, Green H, Galli L, Ramos JT, Giaquinto C, Warszawski J, Levy J; European Infant Collaboration group. Effect of early antiretroviral therapy on the risk of AIDS/death in HIV-infected infants. AIDS. 2009 Mar 13;23(5):597-604. doi: 10.1097/QAD.0b013e328326ca37.

Reference Type RESULT
PMID: 19194272 (View on PubMed)

Collaboration of Observational HIV Epidemiological Research Europe (COHERE) Study Group; Sabin CA, Smith CJ, d'Arminio Monforte A, Battegay M, Gabiano C, Galli L, Geelen S, Gibb D, Guiguet M, Judd A, Leport C, Dabis F, Pantazis N, Porter K, Raffi F, Thorne C, Torti C, Walker S, Warszawski J, Wintergerst U, Chene G, Lundgren J. Response to combination antiretroviral therapy: variation by age. AIDS. 2008 Jul 31;22(12):1463-73. doi: 10.1097/QAD.0b013e3282f88d02.

Reference Type RESULT
PMID: 18614870 (View on PubMed)

Warszawski J, Lechenadec J, Faye A, Dollfus C, Firtion G, Meyer L, Douard D, Monpoux F, Tricoire J, Benmebarek Y, Rouzioux C, Blanche S. Long-term nonprogression of HIV infection in children: evaluation of the ANRS prospective French Pediatric Cohort. Clin Infect Dis. 2007 Sep 15;45(6):785-94. doi: 10.1086/521165. Epub 2007 Aug 14.

Reference Type RESULT
PMID: 17712765 (View on PubMed)

Other Identifiers

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ANRS CO10 EPF

Identifier Type: -

Identifier Source: org_study_id

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