NCT02674867

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

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: ANRS, Emerging Infectious Diseases · Other Government
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• HIV Infection

Interventions

Type	Name	Description
OTHER	Blood draw

Timeline

• Start date: 2016-06-01
• Primary completion: 2019-06-01
• Completion: 2019-06-01
• First posted: 2016-02-05
• Last updated: 2019-01-18

Locations

11 sites across 1 country: France