Informations générales (source: ClinicalTrials.gov)
A Randomised Phase II Placebo-controlled Trial of Antiretroviral Therapy (ART) Plus Dual Long-acting HIV-specific Broadly Neutralising Antibodies (bNAbs) vs ART Plus Placebo During Primary HIV-1 Infection to Study the Impact on Post-treatment HIV Control. (RHIVIERA-02)
Interventional
Phase 2
ANRS, Emerging Infectious Diseases (Voir sur ClinicalTrials)
avril 2024
décembre 2028
05 avril 2025
RHIVIERA-02 trial is a placebo-controlled double-blinded two arm prospective phase II
trial. This study will test the use of broadly neutralising antibodies (bNAbs) in
participants, at primary HIV infection (PHI) and ART initiation.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Valérie GARRAIT | 29/03/2024 01:30:22 | Contacter | ||
| HOPITAL FOCH | DAVID ZUCMAN | 05/05/2025 07:12:11 | Contacter | ||
| 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 | Brigitte Gbaguidi | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Beaujon | Abdelmoula Becharef | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Bichat | Lynda Chalal | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Necker-Enfants Malades | Carole Louisin | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Saint Antoine | Bénédicte Lefebvre | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Tenon | Pelagie Thibaut | 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 | |||||
| CHI Créteil - HdJ - 94010 - Créteil - France | Laurent Richier | Contact (sur clinicalTrials) | |||
| CHI Villeneuve-Saint-Georges - SMIT - 94195 - Villeneuve-Saint-Georges - France | Laurent Richier | Contact (sur clinicalTrials) | |||
| Hôpital Antoine Béclère - 92140 - Clamart - France | Sandrine Poirier | Contact (sur clinicalTrials) | |||
| Hôpital Bicêtre - HdJ - Médecine interne - 94275 - Le Kremlin-Bicêtre - France | Véronique Godard | Contact (sur clinicalTrials) | |||
| Hôpital Hôtel - Dieu - 75004 - Paris - France | Marie-Josée Dulucq | Contact (sur clinicalTrials) | |||
| Hôpital Hôtel Dieu - Service d'immunologie clinique - 75004 - Paris - France | Anne Rachline | Contact (sur clinicalTrials) | |||
| Hôpital Lariboisière - Service de médecine interne A - 75475 - Paris - France | Guylaine Alexandre | Contact (sur clinicalTrials) | |||
| Hôpital Pitié-Salpêtrière - SMIT - 75013 - Paris - France | Yasmine Dudoit | Contact (sur clinicalTrials) | |||
| Hôpital Raymond Poincaré - SMIT - 92380 - Garches - France | Rezak Mahrez | Contact (sur clinicalTrials) | |||
| Hôpital Saint- Louis - SMIT - 75475 - Paris - France | Cylia Imekhlaf | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Confirmed primary HIV-1 infection diagnostic
- Aged ≥18 to ≤70 years old at screening
- Willing to use use an effective method of contraception from the inclusion until the
end of the follow-up in the trial
- Negative plasmatic beta human chorionic gonadotropin (β-HCG) pregnancy test, when
applicable
- Agree not to seek pregnancy including through alternative methods, such as
artificial insemination or in vitro fertilization until after the last required
protocol clinic visit, when applicable
- Informed and written signed consent
- Participant with regular health insurance
- Willing to accept the trial constraints (travel for IMP administration and ART
interruption)
- Willing to be vaccinated against COVID-19 according to recommandations
- Confirmed primary HIV-1 infection diagnostic
- Aged ≥18 to ≤70 years old at screening
- Willing to use use an effective method of contraception from the inclusion until the
end of the follow-up in the trial
- Negative plasmatic beta human chorionic gonadotropin (β-HCG) pregnancy test, when
applicable
- Agree not to seek pregnancy including through alternative methods, such as
artificial insemination or in vitro fertilization until after the last required
protocol clinic visit, when applicable
- Informed and written signed consent
- Participant with regular health insurance
- Willing to accept the trial constraints (travel for IMP administration and ART
interruption)
- Willing to be vaccinated against COVID-19 according to recommandations
- Participation in any other clinical trial requiring additional blood sampling
Participation in an observational study without additional blood sampling is
permitted
- Participants in whom condom use or PrEP use by the partner will be difficult or
impossible
- Pregnant or breastfeeding patient
- Participants under guardianship or curatorship
- Any condition or infection, including HCV, HBV, SARS-CoV-2 or known M. tuberculosis
active infection History of ischemic heart disease (myocardial infarction, stable or
unstable angina, stroke)
- Current or past history of cancer, excluding squamous cell skin cancers
- History or acute known inflammatory ophthalmic affection (uveitis, choroiditis,
optic neuropathy)
- Any medical condition that contraindicates ART interruption
- Concomitant or previous conditions that preclude injection of monoclonal antibodies
- History of systemic corticosteroids, immunosuppressive and anti-cancer medications
within the last 6 months
- History of severe reaction to a vaccine or drug infusion or history of severe
allergic reactions
- Individuals with any contraindication (including hypersensitivity reaction) to
3BNC117-LS and 10-1074-LS infusion
- Prothrombin < 50%
- Creatinine clearance < 60mL/mn (Cockroft)
- ASAT or ALAT or bilirubine (total et conjugated) ≥ 10 times the upper limit of
normal
- Patient with an isolated HIV-2 viral strain
- Planned absence that could affect participation in the trial (travel abroad,
relocation, impending transfer...)