Informations générales (source: ClinicalTrials.gov)
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. (CLEAC)
Interventional
N/A
ANRS, Emerging Infectious Diseases (Voir sur ClinicalTrials)
juin 2016
juin 2019
29 juin 2024
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.
Etablissements
Critères
Tous
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
- 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
- < 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.