Assessment of HIV Remission Upon cART Interruption in Early Treated Individuals Carrying the MHC B35/53Bw4TTC2 Genotype

Last updated: September 28, 2023
Sponsor: ANRS, Emerging Infectious Diseases
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hiv Infections

Treatment

Analytical Treatment Interruption (ATI)

Clinical Study ID

NCT05482854
ANRS 175 RHIVIERA-01
  • Ages > 18
  • All Genders

Study Summary

The aim of the trial is to evaluate in ANRS CO6 PRIMO cohort participants if the presence of the MHC B35 (53) Bw4TTC2 genotype favors the control of HIV infection (defined by a viral load (VL) less than 400 cp/mL) after discontinuation of antiretroviral therapy (ART) initiated during primary HIV infection.

The trial will be a pilot "proof of concept", one arm, multicenter, nested in the ANRS CO6 PRIMO Cohort, in which the intervention is treatment interruption (of at least 6 months).

It is planned to include between 20 and 50 participants.

Eligibility Criteria

Inclusion

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 allelecarrying the Bw4 epitope AND homozygous -21T residue in the HLA-B alleles ANDheterozygous or homozygous for C2 epitope-carrying HLA-C alleles
  • Treated with cART within 3 months following inclusion in ANRS CO6 Primo Cohort duringat 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 thanthe day of pre-inclusion and prior to any examination realized in the frame of thestudy (article L1122-1-1 of the Public Health Code)
  • Person affiliated or beneficiary of a social security scheme (article L1121-11 of thePublic 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

Exclusion Criteria:

  • One VL above 1000 cp/mL on or off antitretrovirals after the initial viral control onantiretrovirals was achieved.
  • Patient on long-acting injectable HIV treatment
  • Patient in whom condom sex use or PrEP use by the partner will be difficult orimpossible.
  • 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, whichcontraindicates the interruption of ARVs.
  • Recent SARS-CoV-2 infection and / or associated with a drop in CD4 and / or associatedwith a resumption of CV in the last 6 months. In this situation, wait until the CD4has returned to a rate > 500/mm3 and a CV < 50 copies / mL consolidated for > 6months.
  • Affection, disability, resulting from a SARS-CoV-2 infection, regardless of theduration of the SARS-CoV-2 infection.
  • Patient participating in another research evaluating other treatments with anexclusion period ongoing at the screening visit.
  • Planned absence which could prevent optimal trial participation (vacation abroad,moving, imminent job change ...).

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Analytical Treatment Interruption (ATI)
Phase:
Study Start date:
March 20, 2023
Estimated Completion Date:
July 31, 2025

Study Description

The ANRS 175 RHIVIERA 01 trial will focus on people who were initiated early and have a particular genotypic profile associated with HIV remission.

The study proposes to test an intervention consisting in a ART-treatment interruption (of at least 6 months) in ANRS CO6 PRIMO cohort participants carrying the MHC B35/53Bw4TTC2 genotype and well controlled on cART.

The study aims to enrol 20-30 participants in 30 French clinical sites. Participants will be enrolled after checking eligibility criteria and will interrupt ART immediatly after inclusion.

Control of HIV-Infection, defined by a viral load less than 400 cp/mL, will be evaluated after 24 weeks of interruption.

Study duration will vary by participant, depending on the time of ART interruption and the time to viral rebound. Participants will be followed maximum 48 weeks on ATI. If there is a viral rebound justifying the resumption of ART, participant will be followed 24 weeks maximum after resumption. The maximum duration of the study will be 48+24 = 72 weeks.

Connect with a study center

  • Centre Hospitalier du Pays d'Aix

    Aix-en-Provence, 13616
    France

    Active - Recruiting

  • Hôtel Dieu

    Angers, 49033
    France

    Site Not Available

  • Hôpital Avicenne

    Bobigny, 93000
    France

    Site Not Available

  • Hôpital PELLEGRIN

    Bordeaux, 33076
    France

    Site Not Available

  • Hôpital Saint-André

    Bordeaux, 33075
    France

    Site Not Available

  • Hôpital de la Côte de Nacre

    Caen, 14033
    France

    Site Not Available

  • Hôpital Gabriel Montpied

    Clermont-Ferrand, 63000
    France

    Site Not Available

  • Hôpital Le Bocage

    Dijon, 21034
    France

    Active - Recruiting

  • Hôpital Pierre Zobda-Quitman

    Fort De France, 97261
    France

    Site Not Available

  • Hôpital Pierre Zobda-Quitman

    Fort-de-France, 97261
    France

    Site Not Available

  • Hôpital Raymond Poincaré

    Garches, 92380
    France

    Active - Recruiting

  • CHD Vendée

    La Roche-sur-Yon, 85925
    France

    Site Not Available

  • Hôpital de Bicêtre

    Le Kremlin-Bicêtre, 94275
    France

    Site Not Available

  • Hôpital Edouard HERRIOT

    Lyon, 69437
    France

    Site Not Available

  • Hôpital de la Croix Rousse

    Lyon, 69317
    France

    Site Not Available

  • Hôpital Sainte Marguerite

    Marseille, 13274
    France

    Site Not Available

  • Hôpital Gui de Chauliac

    Montpellier, 34295
    France

    Site Not Available

  • Hôtel Dieu

    Nantes, 44035
    France

    Active - Recruiting

  • Hôpital Carémeau

    Nîmes, 30029
    France

    Active - Recruiting

  • Hôpital Lariboisière

    Paris, 75475
    France

    Site Not Available

  • Hôpital Saint-Louis

    Paris, 75475
    France

    Active - Recruiting

  • Hôpital Tenon

    Paris, 75970
    France

    Site Not Available

  • Hôpital de l'Hôtel-Dieu

    Paris, 75181
    France

    Active - Recruiting

  • Hôtel Dieu

    Paris, 75004
    France

    Site Not Available

  • Institut Pasteur

    Paris, 75015
    France

    Site Not Available

  • La Pitié Salpêtrière

    Paris, 75013
    France

    Site Not Available

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg, 67091
    France

    Site Not Available

  • Hôpital de Purpan

    Toulouse, 31059
    France

    Active - Recruiting

  • Hôpital Gustave Dron

    Tourcoing, 59027
    France

    Active - Recruiting

  • Hôpital Bretonneau

    Tours, 37044
    France

    Site Not Available

  • CHI Villeneuve Saint Georges

    Villeneuve Saint Georges, 94195
    France

    Site Not Available

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