Informations générales (source: ClinicalTrials.gov)
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
Interventional
N/A
ANRS, Emerging Infectious Diseases (Voir sur ClinicalTrials)
mars 2023
juillet 2025
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Avicenne | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Tenon | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier du Pays d'Aix - 13616 - Aix-en-Provence - France | Christine FAUDON | Contact (sur clinicalTrials) | |||
| CHD Vendée - 85925 - La Roche-sur-Yon - France | Contact (sur clinicalTrials) | ||||
| CHI Villeneuve Saint Georges - 94195 - Villeneuve Saint Georges - France | Contact (sur clinicalTrials) | ||||
| Hôpital Bretonneau - 37044 - Tours - France | Contact (sur clinicalTrials) | ||||
| Hôpital Carémeau - 30029 - Nîmes - France | Régine DONCESCO | Contact (sur clinicalTrials) | |||
| Hôpital de Bicêtre - 94275 - Le Kremlin-Bicêtre - France | Contact (sur clinicalTrials) | ||||
| Hôpital de la Côte de Nacre - 14033 - Caen - France | Contact (sur clinicalTrials) | ||||
| Hôpital de la Croix Rousse - 69317 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Hôpital de l'Hôtel-Dieu - 75181 - Paris - France | Marie-Josée DULUCQ | Contact (sur clinicalTrials) | |||
| Hôpital de Purpan - 31059 - Toulouse - France | Sandra LAGARRIGUE | Contact (sur clinicalTrials) | |||
| Hôpital Edouard HERRIOT - 69437 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Hôpital Gabriel Montpied - 63000 - Clermont-Ferrand - France | Contact (sur clinicalTrials) | ||||
| Hôpital Gui de Chauliac - 34295 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Hôpital Gustave Dron - 59027 - Tourcoing - France | Pauline CORNAVIN | Contact (sur clinicalTrials) | |||
| Hôpital Lariboisière - 75475 - Paris - France | Contact (sur clinicalTrials) | ||||
| Hôpital Le Bocage - 21034 - Dijon - France | Carole CHARLES | Contact (sur clinicalTrials) | |||
| Hôpital PELLEGRIN - 33076 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Hôpital Pierre Zobda-Quitman - 97261 - Fort De France - France | Contact (sur clinicalTrials) | ||||
| Hôpital Raymond Poincaré - 92380 - Garches - France | Rezak MAHREZ | Contact (sur clinicalTrials) | |||
| Hôpital Saint-André - 33075 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Hôpital Sainte Marguerite - 13274 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Hôpital Saint-Louis - 75475 - Paris - France | Jeannine DELGADO | Contact (sur clinicalTrials) | |||
| Hôpitaux Universitaires de Strasbourg - 67091 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Hôtel Dieu - 44035 - Nantes - France | Morane CAVELLEC | Contact (sur clinicalTrials) | |||
| Hôtel Dieu - 49033 - Angers - France | Contact (sur clinicalTrials) | ||||
| Hôtel Dieu - 75004 - Paris - France | Contact (sur clinicalTrials) | ||||
| Institut Pasteur - 75015 - Paris - France | Contact (sur clinicalTrials) | ||||
| La Pitié Salpêtrière - 75013 - Paris - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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.
- 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.
- 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 ...).