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.

ANRS 176 RHIVIERA-02

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.

2024-04-11

2026-12-10

2028-12-10

Recruiting

Early phase I

69

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 Exclusion Criteria: * 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...)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 69, 'type': 'ESTIMATED'}}

2024-04-15