Cohort of HIV-infected Children (EPF)

April 12, 2021 updated by: ANRS, Emerging Infectious Diseases

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
812

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France
        • CHU Angers
      • Besancon, France
        • CHU Hôpital Jean Minjoz
      • Bondy, France
        • Hôpital Jean Verdier
      • Bordeaux, France
        • Centre Hospitalier pellegrin
      • Caen, France
        • CHU Caen
      • Clamart, France
        • Hôpital Antoine Béclère
      • Colombes, France
        • Hopital Louis Mourier
      • Corbeil-Essonnes, France
        • Centre hospitalier Francilien Sud
      • Le Kremlin Bicëtre, France
        • Hôpital Bicêtre
      • Lille, France
        • CHR Jeanne de Flandres
      • Lyon, France
        • Institut d'Hematologie et Oncologie Pediatrique
      • Montpellier, France
        • CHR Arnaud de Villeneuve
      • Montreuil, France
        • Centre Hospitalier Intercommunal
      • Nantes, France
        • CHU Nantes Hôtel Dieu
      • Nice, France
        • CHU Hôpital de l'Archet II
      • Paris, France
        • Hôpital Trousseau
      • Paris, France
        • Hôpital Robert Debré
      • Paris, France
        • Groupe Hospitalier Cochin Tarnier Port-Royal
      • Paris, France
        • Groupe Hospitalier Necker
      • Saint-denis, France
        • Centre Hospitalier Général- Hôpital Delafontaine
      • Strasbourg, France
        • Hôpital Civil
      • Toulouse, France
        • CHU Paule de Viguier
      • Villeneuve Saint Georges, France
        • Centre Hospitalier Général

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
At inclusion and every six months up to 18 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Puberty stage
Time Frame: At 8 years and every six months up to 18 years
Tanner classification
At 8 years and every six months up to 18 years
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)
At inclusion and every six months up to 18 years
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
At inclusion and every six months up to 18 years
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)
At inclusion and every six months up to 18 years
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)
At 15 years and every six months up to 18 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ANRS, Emerging Infectious Diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2004

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ANRS CO10 EPF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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