NCT02674867

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Geographic Reach
1 country

11 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 5, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

January 18, 2019

Status Verified

January 1, 2019

Enrollment Period

3 years

First QC Date

January 13, 2016

Last Update Submit

January 17, 2019

Conditions

HIV Infection

Outcome Measures

Primary Outcomes (5)

  • Immune status

    The immune status will be defined by T lymphocyte subpopulations

    Baseline

  • Virological status

    Peripheral blood HIV DNA levels

    Baseline

  • Immune status

    The immune status will be defined by inflammatory parameters : cytokines and chemokines

    6 months after baseline

  • Immune status

    The immune status will be defined by HIV-specific T cell response

    Baseline

  • Immune status

    The immune status will be defined by lymphocyte activation (HLA-DR)

    Baseline

Secondary Outcomes (3)

  • Comparison of immune and virological statuses of early and late treatment groups

    Baseline

  • Viral reservoir : lymphocyte subpopulation

    One year after baseline

  • Viral reservoir : inductibility

    One year after baseline

Study Arms (2)

Early treatment group

EXPERIMENTAL

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

OTHER

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

Interventions

Blood drawOTHER
Early treatment groupLate treatment group

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • \< 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Hôpital Jean Verdier

Bondy, France

Location

Hôpital Louis Mourier

Colombes, France

Location

Centre Hospitalier Intercommunal

Créteil, France

Location

Centre hospitalier Francilien Sud

Évry, France

Location

Hôpital Bicêtre

Le Kremlin-Bicêtre, France

Location

Groupe hospitalier Cochin Port Royal

Paris, France

Location

Groupe Hospitalier Necker

Paris, France

Location

Hôpital Robert Debré

Paris, France

Location

Hôpital Trousseau

Paris, France

Location

Centre Hospitalier Général- Hôpital Delafontaine

Saint-Denis, France

Location

Centre Hospitalier Général

Villeneuve-Saint-Georges, France

Location

Related Publications (1)

  • 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.

    PMID: 33968064DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2016

First Posted

February 5, 2016

Study Start

June 1, 2016

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

January 18, 2019

Record last verified: 2019-01

Locations

FR(11)