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

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2016 by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
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)
ClinicalTrials.gov Identifier:
NCT02674867
First received: January 13, 2016
Last updated: August 17, 2016
Last verified: August 2016
  Purpose

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 Intervention
HIV Infection Other: Blood draw

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

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

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

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

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

  • Immune status [ Time Frame: Baseline ]
    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 [ 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.

  • 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).

  • 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.


Estimated Enrollment: 80
Study Start Date: June 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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)
  More Information

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
Study First Received: January 13, 2016
Last Updated: August 17, 2016

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

ClinicalTrials.gov processed this record on July 21, 2017