Cohort of HIV-infected Children

NCT03235258 | Completed

• 1 other identifier: ANRS CO10 EPF
• Study Type: observational
• Actual enrollment (reported): 812
• Locations: 1 country
• Sites: 23
• Date type not reported: Study Start
• Actual (reported): Primary Completion
• Actual (reported): Study Completion

Brief Summary

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

Conditions

Children Infected by HIV

Keywords

HIV Infection; Adolescent

Outcome Measures

Primary Outcomes (1)

• Conditions of access to early treatment

  social factors (Geographical origin, living conditions, school level, age) and infection stage

  At inclusion and every six months up to 18 years

Secondary Outcomes (5)

• Puberty stage

  At 8 years and every six months up to 18 years

• Clinical prognosis

  At inclusion and every six months up to 18 years

• Immuno virological prognosis

  At inclusion and every six months up to 18 years

• Prognosis of patient coinfected by CMV or VHC

  At inclusion and every six months up to 18 years

• Sexuality

  At 15 years and every six months up to 18 years

Eligibility Criteria

• Age: Up to 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Cohort of 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

You may qualify if:

• 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

You may not qualify if:

• \>= 13 years
• refusal of legal representative of the child
• antiretroviral therapy started before the entry in care management

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead

Study Sites (23)

CHU Angers

Angers, France

Location

CHU Hôpital Jean Minjoz

Besançon, France

Location

Hôpital Jean Verdier

Bondy, France

Location

Centre Hospitalier Pellegrin

Bordeaux, France

Location

CHU Caen

Caen, France

Location

Hôpital Antoine Béclère

Clamart, France

Location

Hôpital Louis Mourier

Colombes, France

Location

Centre hospitalier Francilien Sud

Corbeil-Essonnes, France

Location

Hôpital Bicêtre

LE Kremlin Bicëtre, France

Location

CHR Jeanne de Flandres

Lille, France

Location

Institut d'Hématologie et Oncologie Pédiatrique

Lyon, France

Location

CHR Arnaud de Villeneuve

Montpellier, France

Location

Centre Hospitalier Intercommunal

Montreuil, France

Location

CHU Nantes Hotel Dieu

Nantes, France

Location

CHU Hôpital de l'Archet II

Nice, France

Location

Groupe Hospitalier Cochin Tarnier Port-Royal

Paris, France

Location

Groupe Hospitalier Necker

Paris, France

Location

Hôpital Robert Debré

Paris, France

Location

Hôpital Trousseau

Paris, France

Location

Centre Hospitalier Général- Hôpital Delafontaine

Saint-Denis, France

Location

Hôpital Civil

Strasbourg, France

Location

CHU Paule de Viguier

Toulouse, France

Location

Centre Hospitalier Général

Villeneuve-Saint-Georges, France

Location

Related Publications (12)

• 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.

  PMID: 26762993 RESULT

• 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.

  PMID: 24945880 RESULT

• 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.

  PMID: 24705410 RESULT

• 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.

  PMID: 24253249 RESULT

• 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.

  PMID: 22427678 RESULT

• 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.

  PMID: 22198788 RESULT

• 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.

  PMID: 21971357 RESULT

• 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.

  PMID: 21511330 RESULT

• 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.

  PMID: 20536367 RESULT

• 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.

  PMID: 19194272 RESULT

• 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.

  PMID: 18614870 RESULT

• 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.

  PMID: 17712765 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

1 to 3 mL whole blood - 1 to 3mL plasma

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Josiane WARSZAWSKI

  CESP INSERM U1018

  PRINCIPAL INVESTIGATOR

Enrollment

812 participants — actual enrollment reported by the registry.

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
• Last Updated: April 13, 2021

Study Start

July 2004

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

June 2020

Actual (reported)

Study Completion

June 2020

Actual (reported)

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (23)