Tests antibody treatment with antiretroviral therapy in early HIV infection
Tests broadly neutralising antibodies alongside HIV medicines in adults with early HIV-1 infection.
Plain-language title generated from the registry record
Registry title: Phase II Trial of ART + Dual bNAbs vs. ART + Placebo During Primary HIV-1 Infection-impact on Post-ART Control
Key facts
- Where
- Bobigny, Clamart, Clichy, Créteil, Garches, Le Kremlin-Bicêtre, Paris, Suresnes, and Villeneuve-Saint-Georges, FranceSee the 17 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT05300035, who can take part
Where in France
- Hôpial Avicenne - SMITBobigny, FranceTaking people
- Hopital Antoine BeclereClamart, FranceTaking people
- Hôpital Beaujon - Service de médecine interneClichy, FranceTaking people
- CHI Créteil - HdJCréteil, FranceTaking people
- Hôpital Raymond Poincaré - SMITGarches, FranceTaking people
- Hôpital Bicêtre - HdJ - Médecine interneLe Kremlin-Bicêtre, FranceTaking people
- Hôpital Bichat - Claude Bernard - SMITParis, FranceTaking people
- Hôpital Hôtel - DieuParis, FranceTaking people
- Hôpital Hôtel Dieu - Service d'immunologie cliniqueParis, FranceNot yet recruiting
- Hôpital Lariboisière - Service de médecine interne AParis, FranceTaking people
- Hôpital Necker - SMITParis, FranceTaking people
- Hôpital Pitié-Salpêtrière - SMITParis, FranceTaking people
- Hôpital Saint-Antoine - SMITParis, FranceTaking people
- Hôpital Saint-Louis - SMITParis, FranceTaking people
- Hôpital Tenon - SMITParis, FranceTaking people
- Centre médico chirurgical Foch - SuresnesSuresnes, FranceTaking people
- CHI Villeneuve-Saint-Georges - SMITVilleneuve-Saint-Georges, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- ANRS, Emerging Infectious Diseases
- Trial code
- NCT05300035
- Record updated
- 27 December 2024
- Original description
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.Read full original descriptionShow less
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.
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.
Inclusion: 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: Concomitant or previous conditions that preclude injection of monoclonal antibodies; 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; Any medical condition that contraindicates ART interruption; 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; Patient with an isolated HIV-2 viral strain; Creatinine clearance < 60mL/mn (Cockroft); 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; History or acute known inflammatory ophthalmic affection (uveitis, choroiditis, optic neuropathy); Prothrombin < 50%; ASAT or ALAT or bilirubine (total et conjugated) ≥ 10 times the upper limit of normal; Planned absence that could affect participation in the trial (travel abroad, relocation, impending transfer...).