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Recruiting Phase 2

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

NCT05300035 · tracked via the Priya Life Science France tracker
Phase
Phase 2
Started
2024-04-11
Last updated
2024-12-27

Condition(s) studied

HIV/AIDS and Infections

Investigational drug(s) / intervention(s)

Recombinant human monoclonal antibody (bNAbs)Placebo

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.

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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...)

Primary outcome measure(s)

  • Proportion of participants with plasma HIV-1 RNA below 400 cp/mL 24 weeks following ATI (W24 ATI), in the confirmed absence of ART. — at Week 24 of antiretroviral treatment interruption period (ATI)
    These participants will be considered as post-treatment controllers.

Trial sites (17)

FacilityCityRegionStatus
Hôpial Avicenne - SMIT Bobigny France Recruiting
Hôpital Antoine Béclère Clamart France Recruiting
Hôpital Beaujon - Service de médecine interne Clichy France Recruiting
CHI Créteil - HdJ Créteil France Recruiting
Hôpital Raymond Poincaré - SMIT Garches France Recruiting
Hôpital Bicêtre - HdJ - Médecine interne Le Kremlin-Bicêtre France Recruiting
Hôpital Hôtel - Dieu Paris France Recruiting
Hôpital Hôtel Dieu - Service d'immunologie clinique Paris France Not Yet Recruiting
Hôpital Pitié-Salpêtrière - SMIT Paris France Recruiting
Hôpital Lariboisière - Service de médecine interne A Paris France Recruiting
Hôpital Saint- Louis - SMIT Paris France Recruiting
Hôpital Saint-Antoine - SMIT Paris France Recruiting
Hôpital Necker - SMIT Paris France Recruiting
Hôpital Bichat - Claude Bernard - SMIT Paris France Recruiting
Hôpital Tenon - SMIT Paris France Recruiting
Centre médico chirurgical Foch - Suresnes Suresnes France Recruiting
CHI Villeneuve-Saint-Georges - SMIT Villeneuve-Saint-Georges France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05300035 on ClinicalTrials.gov ↗ ← All trials in France