Evaluating HIV remission after stopping treatment in early treated individuals with a specific genotype

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial aims to assess whether individuals with the MHC B35/53Bw4TTC2 genotype can maintain control of HIV infection after stopping antiretroviral therapy (ART) for at least six months. Participants will be selected from the ANRS CO6 PRIMO cohort, having been treated early for HIV and showing a well-controlled viral load. The study will involve a one-arm, multicenter approach across 30 clinical sites in France, with a target enrollment of 20-50 participants. The primary outcome will be the evaluation of viral load after 24 weeks of treatment interruption.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Aged 18 years at the time of consent
* Enrolled and currently followed in a site of the ANRS CO6 PRIMO Cohort
* With the MHC genotype: at least one HLA B35 or B53 allele AND one HLA-A or B allele carrying the Bw4 epitope AND homozygous -21T residue in the HLA-B alleles AND heterozygous or homozygous for C2 epitope-carrying HLA-C alleles
* Treated with cART within 3 months following inclusion in ANRS CO6 Primo Cohort during at least 18 months and cART not modified in the last 3 months
* Controlled on cART: \> 90% of VL below 50 cp/mL after initial virological response
* All VL below 50 cp/mL during the previous 12 months
* Most recent CD4 measurement on cART above 500 cells/mm3
* Written and informed consent signed by the person and the investigator (no later than the day of pre-inclusion and prior to any examination realized in the frame of the study (article L1122-1-1 of the Public Health Code)
* Person affiliated or beneficiary of a social security scheme (article L1121-11 of the Public Health Code) (State Medical Aid or AME is not a social security scheme)
* Patient agreeing to participate in the trial according to the defined procedures.

Exclusion Criteria:

* One VL above 1000 cp/mL on or off antitretrovirals after the initial viral control on antiretrovirals was achieved.
* Patient on long-acting injectable HIV treatment
* Patient in whom condom sex use or PrEP use by the partner will be difficult or impossible.
* Woman with a pregnancy project and pregnant woman.
* Patient under guardianship or curatorship.
* History of a clinical AIDS event or cancer.
* Active HCV or HBV infection.
* Any symptoms or laboratory values suggesting a systemic disorder (renal, hepatic, cardiovascular, pulmonary) or other medical conditions, related to HIV or not, which contraindicates the interruption of ARVs.
* Recent SARS-CoV-2 infection and / or associated with a drop in CD4 and / or associated with a resumption of CV in the last 6 months. In this situation, wait until the CD4 has returned to a rate \> 500/mm3 and a CV \< 50 copies / mL consolidated for \> 6 months.
* Affection, disability, resulting from a SARS-CoV-2 infection, regardless of the duration of the SARS-CoV-2 infection.
* Patient participating in another research evaluating other treatments with an exclusion period ongoing at the screening visit.
* Planned absence which could prevent optimal trial participation (vacation abroad, moving, imminent job change ...).

Where it's running

• Centre Hospitalier du Pays d'Aix
  Aix-en-Provence, France Recruiting
• Hôpital Le Bocage
  Dijon, France Recruiting
• Hôpital Raymond Poincaré
  Garches, France Recruiting
• Hôtel Dieu
  Nantes, France Recruiting
• Hôpital Carémeau
  Nîmes, France Recruiting
• Hôpital de l'Hôtel-Dieu
  Paris, France Recruiting

Study contacts

• Principal investigator: Cécile GOUJARD — Hôpital Bicêtre, Service de médecine interne et d'immunologie clinique
• Study coordinator: Vincent MEIFFREDY
• Email: vincent.meiffredy@inserm.fr
• Phone: 00 33 1 45 59 52 06

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.