the ANRS CO21 " Extreme " Cohort (CODEX)
Recruiting · NCT01520844 · Interventional (participants receive a specific treatment) · Lead sponsor: ANRS, Emerging Infectious Diseases
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
Age range
18 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- Under protection(saving) of justice
Where it is running
1 location listed.
- Lambotte - Le Kremlin-Bicêtre, France