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

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 theend of the follow-up in the trial

• Negative plasmatic beta human chorionic gonadotropin (β-HCG) pregnancy test, whenapplicable

• Agree not to seek pregnancy including through alternative methods, such asartificial insemination or in vitro fertilization until after the last requiredprotocol 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 ARTinterruption)

• Willing to be vaccinated against COVID-19 according to recommandations

Exclusion Criteria:

• Participation in any other clinical trial requiring additional blood samplingParticipation in an observational study without additional blood sampling ispermitted

• Participants in whom condom use or PrEP use by the partner will be difficult orimpossible

• Pregnant or breastfeeding patient

• Participants under guardianship or curatorship

• Any condition or infection, including HCV, HBV, SARS-CoV-2 or known M. tuberculosisactive infection History of ischemic heart disease (myocardial infarction, stable orunstable 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 medicationswithin the last 6 months

• History of severe reaction to a vaccine or drug infusion or history of severeallergic 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 ofnormal

• Patient with an isolated HIV-2 viral strain

• Planned absence that could affect participation in the trial (travel abroad,relocation, impending transfer...)