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Completed

NCT Number: NCT03235258

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

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Key information

Conditions

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

Age range

Up to 13 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Angers, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Conditions of access to early treatment

    Time frame: At inclusion and every six months up to 18 years

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

Secondary outcomes

  1. Puberty stage

    Time frame: At 8 years and every six months up to 18 years

    Tanner classification

  2. Clinical prognosis

    Time frame: At inclusion and every six months up to 18 years

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

  3. Immuno virological prognosis

    Time frame: At inclusion and every six months up to 18 years

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

  4. Prognosis of patient coinfected by CMV or VHC

    Time frame: At inclusion and every six months up to 18 years

    Adverse events of treatments (complications)

  5. Sexuality

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Registry information

Official study title

ANRS CO10 EPF - Cohort of HIV-infected Children

Acronym: EPF

Important dates

Study start
2004
Primary completion
2020
Study completion
2020
First posted
Aug 1, 2017
Registry last updated
Apr 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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