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Children Infected by HIVEPFNCT03235258

Cohort of HIV-infected Children

An observational study of Children Infected by HIV, run by ANRS, Emerging Infectious Diseases at 23 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages Up to 13 years
Conditions the study is for
Children Infected by HIV
How many people
812 participants
Where
23 sitesFrance
Study dates
Jul 2004to Jun 2020
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 Up to 13 years
  • All sexes
  • No healthy volunteers
  • Child

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

Who may be able to join

  • 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

Who cannot join

  • >= 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

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

France23 sites

  • CHU Angers

    Angers

  • CHU Hôpital Jean Minjoz

    Besançon

  • Hôpital Jean Verdier

    Bondy

  • Centre Hospitalier Pellegrin

    Bordeaux

  • CHU Caen

    Caen

  • Hôpital Antoine Béclère

    Clamart

  • Hôpital Louis Mourier

    Colombes

  • Centre hospitalier Francilien Sud

    Corbeil-Essonnes

  • Hôpital Bicêtre

    LE Kremlin Bicëtre

  • CHR Jeanne de Flandres

    Lille

  • Institut d'Hématologie et Oncologie Pédiatrique

    Lyon

  • CHR Arnaud de Villeneuve

    Montpellier

  • Centre Hospitalier Intercommunal

    Montreuil

  • CHU Nantes Hotel Dieu

    Nantes

  • CHU Hôpital de l'Archet II

    Nice

  • Groupe Hospitalier Cochin Tarnier Port-Royal

    Paris

  • Groupe Hospitalier Necker

    Paris

  • Hôpital Robert Debré

    Paris

  • Hôpital Trousseau

    Paris

  • Centre Hospitalier Général- Hôpital Delafontaine

    Saint-Denis

  • Hôpital Civil

    Strasbourg

  • CHU Paule de Viguier

    Toulouse

  • Centre Hospitalier Général

    Villeneuve-Saint-Georges

Other trials in France

About this study

Official title: ANRS CO10 EPF - Cohort of HIV-infected Children

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

Read the detailed description

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.

Keywords
HIV Infection, Adolescent
Medical subject headings
HIV Infections

What is being measured

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

  1. Conditions of access to early treatment

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

    Measured: At inclusion and every six months up to 18 years

Secondary outcomes (5)

  1. Puberty stage

    Tanner classification

    Measured: At 8 years and every six months up to 18 years

  2. Clinical prognosis

    Health status (lipodystrophy, metabolic abnormalities, cardiovascular diseases, encephalopathy, Developmental delay, CDC stage)

    Measured: At inclusion and every six months up to 18 years

  3. Immuno virological prognosis

    HIV RNA<50c/mL, CD4 cells count > 500 cells/mL, Genotypic resistance

    Measured: At inclusion and every six months up to 18 years

  4. Prognosis of patient coinfected by CMV or VHC

    Adverse events of treatments (complications)

    Measured: At inclusion and every six months up to 18 years

  5. Sexuality

    sexual risk behaviour (age at first intercourse, condom use at first, contraception, pregnancy, interruption of pregnancy)

    Measured: At 15 years and every six months up to 18 years

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 2004
  3. Primary completionJun 2020
  4. Study completionJun 2020

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
812 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03235258
Sponsor's protocol ID
ANRS CO10 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

  • 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.

    PubMed 26762993

  • 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.

    PubMed 24945880

  • 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.

    PubMed 24705410

  • 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.

    PubMed 24253249

  • 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.

    PubMed 22427678

  • 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.

    PubMed 22198788

  • 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.

    PubMed 21971357

  • 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.

    PubMed 21511330

  • 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.

    PubMed 20536367

  • 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.

    PubMed 19194272

  • 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.

    PubMed 18614870

  • 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.

    PubMed 17712765

Questions about this trial

What is this clinical trial studying?

An observational study of Children Infected by HIV, run by ANRS, Emerging Infectious Diseases at 23 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 1 inclusion and 4 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: finished, 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 23 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Conditions of access to early treatment (time frame: At inclusion and every six months up to 18 years). 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 NCT03235258, which also lists 12 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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