Phase
Condition
N/ATreatment
Recombinant human monoclonal antibody (bNAbs)
Placebo
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
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...)
Study Design
Study Description
Connect with a study center
Hôpial Avicenne - SMIT
Bobigny, 93000
FranceActive - Recruiting
Hôpital Antoine Béclère
Clamart, 92140
FranceActive - Recruiting
Hôpital Beaujon - Service de médecine interne
Clichy, 92110
FranceActive - Recruiting
CHI Créteil - HdJ
Créteil, 94010
FranceActive - Recruiting
Hôpital Raymond Poincaré - SMIT
Garches, 92380
FranceActive - Recruiting
Hôpital Bicêtre - HdJ - Médecine interne
Le Kremlin-Bicêtre, 94275
FranceActive - Recruiting
Hôpital Bichat - Claude Bernard - SMIT
Paris, 75877
FranceActive - Recruiting
Hôpital Hôtel - Dieu
Paris, 75004
FranceActive - Recruiting
Hôpital Hôtel Dieu - Service d'immunologie clinique
Paris, 75004
FranceSite Not Available
Hôpital Lariboisière - Service de médecine interne A
Paris, 75475
FranceActive - Recruiting
Hôpital Necker - SMIT
Paris, 75743
FranceActive - Recruiting
Hôpital Pitié-Salpêtrière - SMIT
Paris, 75013
FranceActive - Recruiting
Hôpital Saint- Louis - SMIT
Paris, 75475
FranceActive - Recruiting
Hôpital Saint-Antoine - SMIT
Paris, 75571
FranceActive - Recruiting
Hôpital Tenon - SMIT
Paris, 75970
FranceActive - Recruiting
Centre médico chirurgical Foch - Suresnes
Suresnes, 92151
FranceActive - Recruiting
CHI Villeneuve-Saint-Georges - SMIT
Villeneuve-Saint-Georges, 94195
FranceActive - Recruiting
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