Phase II Trial of ART + Dual bNAbs vs. ART + Placebo During Primary HIV-1 Infection-impact on Post-ART Control
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: HIV/AIDS and Infections
In brief
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.
Key facts
- Study ID
- NCT05300035
- Run by
- ANRS, Emerging Infectious Diseases
- People needed
- 69
- Starts
- 2024-04-11
- Expected to finish
- 2028-12-10
- Last updated by the study team
- 2024-12-27
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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...)
Where it is running
- CHI Villeneuve-Saint-Georges - SMIT — Villeneuve-Saint-Georges, France (enrolling)
- Hôpital Bichat - Claude Bernard - SMIT — Paris, France (enrolling)
- Hôpial Avicenne - SMIT — Bobigny, France (enrolling)
- Hôpital Antoine Béclère — Clamart, France (enrolling)
- Hôpital Beaujon - Service de médecine interne — Clichy, France (enrolling)
- CHI Créteil - HdJ — Créteil, France (enrolling)
- Hôpital Raymond Poincaré - SMIT — Garches, France (enrolling)
- Hôpital Bicêtre - HdJ - Médecine interne — Le Kremlin-Bicêtre, France (enrolling)
- Hôpital Hôtel - Dieu — Paris, France (enrolling)
- Hôpital Necker - SMIT — Paris, France (enrolling)
- Hôpital Pitié-Salpêtrière - SMIT — Paris, France (enrolling)
- Hôpital Lariboisière - Service de médecine interne A — Paris, France (enrolling)
- Hôpital Saint- Louis - SMIT — Paris, France (enrolling)
- Hôpital Saint-Antoine - SMIT — Paris, France (enrolling)
- Hôpital Tenon - SMIT — Paris, France (enrolling)
- Centre médico chirurgical Foch - Suresnes — Suresnes, France (enrolling)
- Hôpital Hôtel Dieu - Service d'immunologie clinique — Paris, France
Full record on ClinicalTrials.gov
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