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

HIV Infection Clinical Trial

— CLEAC  

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02674867
• Other study ID #: ANRS EP 59 CLEAC
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2016
• Est. completion date: June 2019

Study information

• Verified date: January 2019
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections

Intervention

Other:
• Blood draw

Locations

Country	Name	City	State
France	Hôpital Jean Verdier	Bondy
France	Hôpital Louis Mourier	Colombes
France	Centre Hospitalier Intercommunal	Créteil
France	Centre hospitalier Francilien Sud	Evry
France	Hôpital Bicêtre	Le Kremlin Bicêtre
France	Groupe hospitalier Cochin Port Royal	Paris
France	Groupe Hospitalier Necker	Paris
France	Hôpital Robert Debré	Paris
France	Hôpital Trousseau	Paris
France	Centre Hospitalier Général- Hôpital Delafontaine	Saint Denis
France	Centre Hospitalier Général	Villeneuve Saint Georges

Sponsors (1)

Lead Sponsor	Collaborator
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immune status	The immune status will be defined by T lymphocyte subpopulations	Baseline
Primary	Virological status	Peripheral blood HIV DNA levels	Baseline
Primary	Immune status	The immune status will be defined by inflammatory parameters : cytokines and chemokines	6 months after baseline
Primary	Immune status	The immune status will be defined by HIV-specific T cell response	Baseline
Primary	Immune status	The immune status will be defined by lymphocyte activation (HLA-DR)	Baseline
Secondary	Comparison of immune and virological statuses of early and late treatment groups	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.	Baseline
Secondary	Viral reservoir : lymphocyte subpopulation	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).	One year after baseline
Secondary	Viral reservoir : inductibility	Inductibility of the viral reservoir will be quantified by ultrasensitive HIV-RNA RT- PCR in supernatants after coculture of CD4 T cells.	One year after baseline