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RECRUITINGPhase 2INTERVENTIONAL

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

A Randomised Phase II Placebo-controlled Trial of Antiretroviral Therapy (ART) Plus Dual Long-acting HIV-specific Broadly Neutralising Antibodies (bNAbs) vs ART Plus Placebo During Primary HIV-1 Infection to Study the Impact on Post-treatment HIV Control.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 according to recommandations 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...)

Treatments Being Tested

DRUG

Recombinant human monoclonal antibody (bNAbs)

1. Initiation of combination ART (1 integrase inhibitor + 2 nucleoside analogue reverse transcriptase inhibitors) with additional dual intravenous infusions of bNAbs (3BNC117LS \& 10-1074LS) between Day 7 and Day 10. 2. Analytical treatment interruption (ATI), 52 weeks later, if good immunologic and virologic conditions. 3. During ATI, plasma HIV-1 RNA and CD4 monitoring, for a maximum of 48 weeks. 4. ART resumption, if participant encounters at least one ART resumption criteria.

DRUG

Placebo

1. Initiation of combination ART (1 integrase inhibitor + 2 nucleoside analogue reverse transcriptase inhibitors) with additional dual intravenous infusions of placebo (saline solution) between Day 7 and Day 10. 2. Analytical treatment interruption (ATI), 52 weeks later, if good immunologic and virologic conditions. 3. During ATI, plasma HIV-1 RNA and CD4 monitoring, for a maximum of 48 weeks. 4. ART resumption, if participant encounters at least one ART resumption criteria.

Locations (17)

Hôpial Avicenne - SMIT
Bobigny, France
Hôpital Antoine Béclère
Clamart, France
Hôpital Beaujon - Service de médecine interne
Clichy, France
CHI Créteil - HdJ
Créteil, France
Hôpital Raymond Poincaré - SMIT
Garches, France
Hôpital Bicêtre - HdJ - Médecine interne
Le Kremlin-Bicêtre, France
Hôpital Hôtel - Dieu
Paris, France
Hôpital Hôtel Dieu - Service d'immunologie clinique
Paris, France
Hôpital Pitié-Salpêtrière - SMIT
Paris, France
Hôpital Lariboisière - Service de médecine interne A
Paris, France
Hôpital Saint- Louis - SMIT
Paris, France
Hôpital Saint-Antoine - SMIT
Paris, France
Hôpital Necker - SMIT
Paris, France
Hôpital Bichat - Claude Bernard - SMIT
Paris, France
Hôpital Tenon - SMIT
Paris, France
Centre médico chirurgical Foch - Suresnes
Suresnes, France
CHI Villeneuve-Saint-Georges - SMIT
Villeneuve-Saint-Georges, France