Cohort of HIV-infected Children

Completed

• Conditions: Children Infected by HIV

• Registration Number: NCT03235258
• Lead Sponsor: ANRS, Emerging Infectious Diseases

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

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.

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2016-09-29
• Study First Submitted QC: 2017-07-27
• Study First Posted: 2017-08-01
• Primary Completion: 2020-06
• Study Completion: 2020-06
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-12
• Last Update Posted: 2021-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 812

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Conditions of access to early treatment	At inclusion and every six months up to 18 years	social factors (Geographical origin, living conditions, school level, age) and infection stage

Secondary Outcome Measures

Name	Time	Method
Puberty stage	At 8 years and every six months up to 18 years	Tanner classification
Sexuality	At 15 years and every six months up to 18 years	sexual risk behaviour (age at first intercourse, condom use at first, contraception, pregnancy, interruption of pregnancy)
Immuno virological prognosis	At inclusion and every six months up to 18 years	HIV RNA\<50c/mL, CD4 cells count \> 500 cells/mL, Genotypic resistance
Clinical prognosis	At inclusion and every six months up to 18 years	Health status (lipodystrophy, metabolic abnormalities, cardiovascular diseases, encephalopathy, Developmental delay, CDC stage)
Prognosis of patient coinfected by CMV or VHC	At inclusion and every six months up to 18 years	Adverse events of treatments (complications)

Trial Locations

Locations (23)

Hôpital Robert Debré; 🇫🇷 Paris, France

Hôpital Bicêtre; 🇫🇷 Le Kremlin Bicëtre, France

Centre Hospitalier Intercommunal; 🇫🇷 Montreuil, France

Groupe Hospitalier Cochin Tarnier Port-Royal; 🇫🇷 Paris, France

CHR Jeanne de Flandres; 🇫🇷 Lille, France

Hôpital Trousseau; 🇫🇷 Paris, France

CHU Angers; 🇫🇷 Angers, France

Centre Hospitalier Pellegrin; 🇫🇷 Bordeaux, France

CHU Caen; 🇫🇷 Caen, France

Hôpital Louis Mourier; 🇫🇷 Colombes, France

CHU Nantes Hotel Dieu; 🇫🇷 Nantes, France

Centre Hospitalier Général- Hôpital Delafontaine; 🇫🇷 Saint-denis, France

Hôpital Antoine Béclère; 🇫🇷 Clamart, France

Centre hospitalier Francilien Sud; 🇫🇷 Corbeil-Essonnes, France

Centre Hospitalier Général; 🇫🇷 Villeneuve Saint Georges, France

Groupe Hospitalier Necker; 🇫🇷 Paris, France

CHU Paule de Viguier; 🇫🇷 Toulouse, France

CHU Hôpital Jean Minjoz; 🇫🇷 Besancon, France

Hôpital Jean Verdier; 🇫🇷 Bondy, France

CHR Arnaud de Villeneuve; 🇫🇷 Montpellier, France

CHU Hôpital de l'Archet II; 🇫🇷 Nice, France

Institut d'Hématologie et Oncologie Pédiatrique; 🇫🇷 Lyon, France

Hôpital Civil; 🇫🇷 Strasbourg, France