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

ANRS 175 RHIVIERA-01: Assessment of HIV Remission Upon Combination Antiretroviral Therapy (cART) Interruption in Early Treated Individuals From ANRS CO6 PRIMO Cohort Carrying the Major Histocompatibility Complex (MHC) B35/53Bw4TTC2 Genotype

NA · ANRS, Emerging Infectious Diseases · NCT05482854

This study is testing if people with a specific genetic makeup can keep their HIV under control for six months after stopping their medication.

Quick facts

PhaseNA
Study typeInterventional
Enrollment50 (estimated)
Ages18 Years and up
SexAll
SponsorANRS, Emerging Infectious Diseases (other gov)
Drugs / interventionscART
Locations30 sites (Aix-en-Provence and 29 other locations)
Trial IDNCT05482854 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with specific genetic markers who have been on stable ART and have maintained a low viral load.

Not a fit: Patients who do not carry the required MHC genotype or have not achieved stable viral load control on ART may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new strategies for managing HIV without continuous antiretroviral therapy for certain patients.

How similar studies have performed: While this approach is novel in its specific genetic focus, previous studies have explored treatment interruption in HIV, with varying degrees of success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Aix-en-Provence and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: HIV Infections, treatment interruption, HIV remission, Post-treatment control, HLA-B35, Early treatment

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.