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

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ClinicalTrials.gov Identifier: NCT02674867
Recruitment Status : Recruiting
First Posted : February 5, 2016
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

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.


Condition or disease Intervention/treatment Phase
HIV Infection Other: Blood draw Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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 Start Date : June 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Early treatment group
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.
Other: Blood draw
Late treatment group
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.
Other: Blood draw



Primary Outcome Measures :
  1. Immune status [ Time Frame: Baseline ]
    The immune status will be defined by T lymphocyte subpopulations

  2. Virological status [ Time Frame: Baseline ]
    Peripheral blood HIV DNA levels

  3. Immune status [ Time Frame: 6 months after baseline ]
    The immune status will be defined by inflammatory parameters : cytokines and chemokines

  4. Immune status [ Time Frame: Baseline ]
    The immune status will be defined by HIV-specific T cell response

  5. Immune status [ Time Frame: Baseline ]
    The immune status will be defined by lymphocyte activation (HLA-DR)


Secondary Outcome Measures :
  1. Comparison of immune and virological statuses of early and late treatment groups [ Time Frame: Baseline ]
    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.

  2. Viral reservoir : lymphocyte subpopulation [ Time Frame: One year after baseline ]
    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).

  3. Viral reservoir : inductibility [ Time Frame: One year after baseline ]
    Inductibility of the viral reservoir will be quantified by ultrasensitive HIV-RNA RT- PCR in supernatants after coculture of CD4 T cells.



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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02674867


Contacts
Contact: Pierre FRANGE +33 1 44 49 48 22 pierre.frange@nck.aphp.fr
Contact: Josiane WARSZAWSKI +33 1 49 59 53 05 josiane.warszawski@inserm.fr

Locations
France
Hôpital Jean Verdier Not yet recruiting
Bondy, France
Principal Investigator: Eric LAGRASSINE, MD         
Hôpital Louis Mourier Not yet recruiting
Colombes, France
Principal Investigator: Corinne FLOCH-TUDAL, MD         
Centre Hospitalier Intercommunal Not yet recruiting
Créteil, France
Principal Investigator: Isabelle HAU, MD         
Centre hospitalier Francilien Sud Not yet recruiting
Evry, France
Principal Investigator: Michèle GRANIER, MD         
Hôpital Bicêtre Not yet recruiting
Le Kremlin Bicêtre, France
Principal Investigator: Corinne FOURCADE, MD         
Groupe hospitalier Cochin Port Royal Not yet recruiting
Paris, France
Principal Investigator: Ghislaine FIRTION, MD         
Groupe Hospitalier Necker Recruiting
Paris, France
Principal Investigator: Pierre FRANGE, MD         
Hôpital Robert Debré Not yet recruiting
Paris, France
Contact: Eriana BELLATON, MD         
Principal Investigator: Albert FAYE, MD         
Hôpital Trousseau Not yet recruiting
Paris, France
Principal Investigator: Catherine DOLLFUS, MD         
Centre Hospitalier Général- Hôpital Delafontaine Not yet recruiting
Saint Denis, France
Principal Investigator: Cécile GAKOBWA, MD         
Centre Hospitalier Général Not yet recruiting
Villeneuve Saint Georges, France
Principal Investigator: Anne CHACE, MD         
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT02674867     History of Changes
Other Study ID Numbers: ANRS EP 59 CLEAC
First Posted: February 5, 2016    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases