ANRS CODEX 'Extreme' cohort of people who naturally control HIV

Multicentric Cohort of HIV Patient With Extrem Profil

This project tests blood markers in adults with long-term HIV control without antiretroviral therapy to learn what helps their immune system keep the virus in check.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 450 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: ANRS, Emerging Infectious Diseases (other gov)
• Locations: 1 site (Le Kremlin-Bicêtre)
• Trial ID: NCT01520844 on ClinicalTrials.gov

What this trial studies

The cohort combines several French groups of rare HIV cases who maintain high CD4 counts or very low viral loads for many years without treatment. Participants provide blood samples for detailed immunological, virological, and genetic analyses to characterize viral reservoirs and immune responses, particularly CD8 T‑cell control. The protocol enrolls adults with documented long-standing HIV-1 infection who meet strict virological or immunological criteria and are able to attend the Lambotte center. Findings so far from related ANRS cohorts have identified small viral reservoirs and host genetic and immune features associated with control, which this consortium continues to define in greater depth.

Who should consider this trial

Good fit: Adults (≥18) with documented HIV-1 infection known for at least 5–8 years who are off antiretroviral therapy and meet the cohort definitions (long-term high CD4 counts or consecutive low viral loads), able to consent and covered by French social security are ideal candidates.

Not a fit: People currently on continuous antiretroviral therapy, those with recent HIV diagnosis, HIV-2 co‑infection, under 18, or unable to attend the French study site are unlikely to qualify or benefit from this specific cohort protocol.

Why it matters

Potential benefit: If successful, the work could identify immune or genetic signatures that guide new vaccine, immune-based, or cure strategies for HIV.

How similar studies have performed: Previous ANRS cohorts (CO15 ALT, CO18 HIC, VISCONTI) have already produced important findings showing replication-competent virus with small reservoirs and distinctive host immune/genetic features, so the approach has a track record of informative results.

Eligibility criteria

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 this trial is running

Le Kremlin-Bicêtre

• Lambotte — Le Kremlin-Bicêtre, France (RECRUITING)

Study contacts

• Principal investigator: Olivier Lambotte, Professor — Kremlin Bicetre
• Study coordinator: Olivier Lambotte, Professor

Conditions: HIV Infection