Status:
UNKNOWN
the ANRS CO21 " Extreme " Cohort (CODEX)
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Conditions:
HIV Infection
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
A consortium of research teams has studied the immunovirological characteristics of these patients: The ANRS CO15 ALT cohort The ANRS CO18 HIV Controller cohort the ANRS EP47 VISCONTI study
Detailed Description
Two cohorts of patients with a phenotype of HIV resistance exist in France. The ANRS CO15 ALT cohort was set up in 1994. 71 patients were enrolled defined on immunological criteria: CD4 T cell count a...
Eligibility Criteria
Inclusion
- Patient infected with HIV-1 and not co-infected with HIV-2
- Age ≥ 18 at enrollment
- Able to give written consent
- Covered by French Social Security
- accept the constraints imposed by the study
- without antiretroviral therapy for ALT, HIC and ALT HIC groups and a control of viral load after antiretroviral treatment interruption in PTC group
- ALT group: Documented HIV-1 seropositive for at least 8 years with a CD4 count above 600/mm3 with a rate stable or increasing (positive or zero slope) on at least three consecutive examinations performed during the last 5 years regardless of the viral load in the absence of antiretroviral treatment
- HIC group: HIV-1 Seropositivity known for at least five years, asymptomatic, with the last 5 viral loads in HIV-RNA consecutive \<400 copies / mL regardless of CD4 count in the absence of antiretroviral treatment
- ALT HIC group: HIV-1 seropositive known for at least 8 years and CD4 cell counts greater than 600/mm3 with a rate stable or increasing (positive or zero slope) on at least three consecutive examinations performed during the last 5 years and with the last 5 viral loads in HIV-RNA consecutive \<400 copies / mL in the absence of antiretroviral therapy.
- PTC group: Patients with plasma HIV RNA \> 2000 copies/mL before initiation of antiretroviral therapy. Treatment started during the primary infection (as defined by symptoms associated with seroconversion, as confirmed by a first negative ELISA and/or an incomplete P24-positive Western blot) or during the chronic phase of infection, and maintained for at least 12 months in both cases. Control of viral load after antiretroviral treatment interruption: patients must have at least two available viral load assays after stopping antiretroviral therapy. All viral loads must be \<400 copies/mL for 12 months or more after stopping antiretroviral therapy, with the possible exception of one blip (one viral load above 400 copies/mL between two viral loads \<400 copies/mL at least one month apart from the blip; in this case at least three viral load assays will be required). The last plasma viral load value at the time of inclusion must always be \<400 copies/mL
Exclusion
- Under protection(saving) of justice
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2023
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01520844
Start Date
February 1 2012
End Date
September 1 2023
Last Update
July 24 2019
Active Locations (1)
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1
Lambotte
Le Kremlin-Bicêtre, France