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

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...)