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CLEAC (Comparison of Late Versus Early Antiretroviral Therapy in HIV-infected Children) (CLEAC)

Primary Purpose

HIV Infection

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood draw
Sponsored by
ANRS, Emerging Infectious Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for HIV Infection

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 5 to 17 years old
  • Vertically HIV-1 infected, not HIV-2 co-infected
  • Diagnosed < 13 years old
  • Usually followed in a center participating in the ANRS CO10 EPF cohort located in Ile de France

  • Have received cART treatment:

    • started later than 6 months-of-age ("early treatment" group) or after 24 months-of-age ("late treatment" group)
    • with an initial virologic success (HIV-1 RNA <400 copies / mL reached no later than 24 months after the start of cART),
  • Affiliated person or beneficiary of a social security system (Article L1121-11 of the Code of Public Health) (medical aid of state or AME is not a social security system)
  • Participant agreement if in age to give an opinion
  • Free, informed and written consent, signed by at least one parent and the investigator

Exclusion Criteria:

  • < 5 years old or ≥ 18 years old at first sample for the study
  • Obviously HIV-1 infected after the perinatal period
  • HIV-2 co-infected
  • Diagnosed ≥ 13 years old
  • Started cART treatment between 7 and 23 months
  • No HIV-1 RNA <400 copies / mL within 24 months after initiation of treatment (considered as a failure of the first line therapy)
  • Not affiliated to the French social security, or beneficiary of a social security system
  • Refusal to participation of parent(s) (or the holders(s) of parental authority)
  • Refusal to participation if in age to give an opinion.

Sites / Locations

  • Hôpital Jean Verdier
  • Hôpital Louis Mourier
  • Centre Hospitalier Intercommunal
  • Centre hospitalier Francilien Sud
  • Hôpital Bicêtre
  • Groupe hospitalier Cochin Port Royal
  • Groupe Hospitalier Necker
  • Hôpital Robert Debré
  • Hôpital Trousseau
  • Centre Hospitalier Général- Hôpital Delafontaine
  • Centre Hospitalier Général

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Early treatment group

Late treatment group

Arm Description

Vertically-HIV-1-infected children, between 5 and 17-year-of-age, who started cART before 6 months-of-age ("early treatment" group) with an initial virologic success (HIV-1 RNA <400 copies / mL reached no later than 24 months after the start of cART), whatever the later evolution of the viremia.

Vertically-HIV-1-infected children, between 5 and 17-year-of-age, who started cART after 24 months-of-age ("late treatment" group) with an initial virologic success (HIV-1 RNA <400 copies / mL reached no later than 24 months after the start of cART), whatever the later evolution of the viremia.

Outcomes

Primary Outcome Measures

Immune status
The immune status will be defined by T lymphocyte subpopulations
Virological status
Peripheral blood HIV DNA levels
Immune status
The immune status will be defined by inflammatory parameters : cytokines and chemokines
Immune status
The immune status will be defined by HIV-specific T cell response
Immune status
The immune status will be defined by lymphocyte activation (HLA-DR)

Secondary Outcome Measures

Comparison of immune and virological statuses of early and late treatment groups
Two groups of vertically-HIV-1-infected children, between 5 and 18-year-of-age, will be compared: the "early treatment" group that comprises children who started HAART before 6 months-of-age, and the late treatment" group those who started HAART after 24 months-of-age.
Viral reservoir : lymphocyte subpopulation
Total HIV- DNA will be quantified by ultrasensitive PCR in CD4 T cell subsets sorted according their differenciation status for 10 children (5 patients in each group) with sustained control of the HIV-1 viremia under HAART ( ≥ 90% of HIV-1 RNA measures <400 copies / ml).
Viral reservoir : inductibility
Inductibility of the viral reservoir will be quantified by ultrasensitive HIV-RNA RT- PCR in supernatants after coculture of CD4 T cells.

Full Information

First Posted
January 13, 2016
Last Updated
January 17, 2019
Sponsor
ANRS, Emerging Infectious Diseases
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1. Study Identification

Unique Protocol Identification Number
NCT02674867
Brief Title
CLEAC (Comparison of Late Versus Early Antiretroviral Therapy in HIV-infected Children)
Acronym
CLEAC
Official Title
ANRS EP59 CLEAC : Physiopathological Study of Immunovirological Evolution of Perinatally HIV-1 Infected Children Depending on Early (Before 6 Months) or Late (After 2 Years) Antiretroviral Therapy Introduction.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ANRS, Emerging Infectious Diseases

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study aims to define and compare the immunological characteristics (lymphocyte subpopulations, specific immunity against HIV, lymphocyte activation, inflammatory parameters) and the virological characteristics (study of viral reservoir) between 2 groups of vertically-HIV-1-infected children, between 5 and 17-year-of-age, who started cART before 6 months-of-age ("early treatment" group) or after 24 months-of-age ("late treatment" group) with an initial virologic success (HIV-1 RNA <400 copies / mL reached no later than 24 months after the start of cART), whatever the later evolution of the viremia. Moreover, the viral reservoir will be deeply characterized in 10 children (5 patients in each group) with sustained control of the HIV-1 viremia under cART (≥ 90% of HIV-1 RNA measures <400 copies /mL): quantification of the reservoir in the lymphocyte subpopulations and study of the inductibility of the viral reservoir.
Detailed Description
This is a cross-sectional study, multicenter, without direct benefit, among vertically HIV-1 infected children, aged 5 to 17 years, followed in centers participating in the ANRS CO10 EPF cohort located in Ile-de-France. Eligible children are not necessarily included in the cohort. The sample will consist of two age groups of equal size (5-12 years and 13-17 years). Patient recruitment will be conducted in the centers of the ANRS CO10 EPF cohort located in Ile de France (Paris area). 80 children will be included, previously included or not in the ANRS CO10 EPF cohort. Our investigations will involve two blood samples, taken during two successive visits of the children in the hospitals where they are usually followed. Finally, a third blood sample will be taken during a third visit only for the 10 children participating in the substudy of the viral reservoir. All medical data since birth will be prospectively collected for children included in the ANRS CO10 EPF cohort, and retrospectively collected in the other cases.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early treatment group
Arm Type
Experimental
Arm Description
Vertically-HIV-1-infected children, between 5 and 17-year-of-age, who started cART before 6 months-of-age ("early treatment" group) with an initial virologic success (HIV-1 RNA <400 copies / mL reached no later than 24 months after the start of cART), whatever the later evolution of the viremia.
Arm Title
Late treatment group
Arm Type
Other
Arm Description
Vertically-HIV-1-infected children, between 5 and 17-year-of-age, who started cART after 24 months-of-age ("late treatment" group) with an initial virologic success (HIV-1 RNA <400 copies / mL reached no later than 24 months after the start of cART), whatever the later evolution of the viremia.
Intervention Type
Other
Intervention Name(s)
Blood draw
Primary Outcome Measure Information:
Title
Immune status
Description
The immune status will be defined by T lymphocyte subpopulations
Time Frame
Baseline
Title
Virological status
Description
Peripheral blood HIV DNA levels
Time Frame
Baseline
Title
Immune status
Description
The immune status will be defined by inflammatory parameters : cytokines and chemokines
Time Frame
6 months after baseline
Title
Immune status
Description
The immune status will be defined by HIV-specific T cell response
Time Frame
Baseline
Title
Immune status
Description
The immune status will be defined by lymphocyte activation (HLA-DR)
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Comparison of immune and virological statuses of early and late treatment groups
Description
Two groups of vertically-HIV-1-infected children, between 5 and 18-year-of-age, will be compared: the "early treatment" group that comprises children who started HAART before 6 months-of-age, and the late treatment" group those who started HAART after 24 months-of-age.
Time Frame
Baseline
Title
Viral reservoir : lymphocyte subpopulation
Description
Total HIV- DNA will be quantified by ultrasensitive PCR in CD4 T cell subsets sorted according their differenciation status for 10 children (5 patients in each group) with sustained control of the HIV-1 viremia under HAART ( ≥ 90% of HIV-1 RNA measures <400 copies / ml).
Time Frame
One year after baseline
Title
Viral reservoir : inductibility
Description
Inductibility of the viral reservoir will be quantified by ultrasensitive HIV-RNA RT- PCR in supernatants after coculture of CD4 T cells.
Time Frame
One year after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 5 to 17 years old Vertically HIV-1 infected, not HIV-2 co-infected Diagnosed < 13 years old Usually followed in a center participating in the ANRS CO10 EPF cohort located in Ile de France Have received cART treatment: started later than 6 months-of-age ("early treatment" group) or after 24 months-of-age ("late treatment" group) with an initial virologic success (HIV-1 RNA <400 copies / mL reached no later than 24 months after the start of cART), Affiliated person or beneficiary of a social security system (Article L1121-11 of the Code of Public Health) (medical aid of state or AME is not a social security system) Participant agreement if in age to give an opinion Free, informed and written consent, signed by at least one parent and the investigator Exclusion Criteria: < 5 years old or ≥ 18 years old at first sample for the study Obviously HIV-1 infected after the perinatal period HIV-2 co-infected Diagnosed ≥ 13 years old Started cART treatment between 7 and 23 months No HIV-1 RNA <400 copies / mL within 24 months after initiation of treatment (considered as a failure of the first line therapy) Not affiliated to the French social security, or beneficiary of a social security system Refusal to participation of parent(s) (or the holders(s) of parental authority) Refusal to participation if in age to give an opinion.
Facility Information:
Facility Name
Hôpital Jean Verdier
City
Bondy
Country
France
Facility Name
Hôpital Louis Mourier
City
Colombes
Country
France
Facility Name
Centre Hospitalier Intercommunal
City
Créteil
Country
France
Facility Name
Centre hospitalier Francilien Sud
City
Evry
Country
France
Facility Name
Hôpital Bicêtre
City
Le Kremlin Bicêtre
Country
France
Facility Name
Groupe hospitalier Cochin Port Royal
City
Paris
Country
France
Facility Name
Groupe Hospitalier Necker
City
Paris
Country
France
Facility Name
Hôpital Robert Debré
City
Paris
Country
France
Facility Name
Hôpital Trousseau
City
Paris
Country
France
Facility Name
Centre Hospitalier Général- Hôpital Delafontaine
City
Saint Denis
Country
France
Facility Name
Centre Hospitalier Général
City
Villeneuve Saint Georges
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
33968064
Citation
Frange P, Montange T, Le Chenadec J, Batalie D, Fert I, Dollfus C, Faye A, Blanche S, Chace A, Fourcade C, Hau I, Levine M, Mahlaoui N, Marcou V, Tabone MD, Veber F, Hoctin A, Wack T, Avettand-Fenoel V, Warszawski J, Buseyne F. Impact of Early Versus Late Antiretroviral Treatment Initiation on Naive T Lymphocytes in HIV-1-Infected Children and Adolescents - The-ANRS-EP59-CLEAC Study. Front Immunol. 2021 Apr 22;12:662894. doi: 10.3389/fimmu.2021.662894. eCollection 2021.
Results Reference
derived

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CLEAC (Comparison of Late Versus Early Antiretroviral Therapy in HIV-infected Children)

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