Phase II Trial of ART + Dual bNAbs vs. ART + Placebo During Primary HIV-1 Infection-impact on Post-ART Control

• Status: Not yet recruiting
• Trial end date: 2028-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ANRS, Emerging Infectious Diseases
• Collaborators: Institut Pasteur; Rockefeller University
• Treatments: Antibodies; Antibodies, Monoclonal

Criteria

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 before ART interruption.

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 (SARS-CoV-2 PCR positive for less than 72 hours) 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...)