HIV Infection Clinical Trial
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.
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.
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.
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