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

Prior treatment

• Concomitant or previous conditions that preclude injection of monoclonal antibodies

Other illness

• 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
• Any medical condition that contraindicates ART interruption
• 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
• Patient with an isolated HIV-2 viral strain

Lab values

• Creatinine clearance \< 60mL/mn (Cockroft)

Other

• 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
• History or acute known inflammatory ophthalmic affection (uveitis, choroiditis, optic neuropathy)
• Prothrombin \< 50%
• ASAT or ALAT or bilirubine (total et conjugated) ≥ 10 times the upper limit of normal
• Planned absence that could affect participation in the trial (travel abroad, relocation, impending transfer...)

• 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