RecruitingNot ApplicableNCT01520844

the ANRS CO21 " Extreme " Cohort (CODEX)

Multicentric Cohort of HIV Patient With Extrem Profil


Sponsor

ANRS, Emerging Infectious Diseases

Enrollment

450 participants

Start Date

Feb 1, 2012

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria10

  • 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 Criteria1

  • Under protection(saving) of justice

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Interventions

BIOLOGICALblood sampling

blood sampling


Locations(1)

Lambotte

Le Kremlin-Bicêtre, France

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NCT01520844


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