NCT05300035 Phase II Trial of ART + Dual bNAbs vs. ART + Placebo During Primary HIV-1 Infection-impact on Post-ART Control
| NCT ID | NCT05300035 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | ANRS, Emerging Infectious Diseases |
| Condition | HIV/AIDS and Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 69 participants |
| Start Date | 2024-04-11 |
| Primary Completion | 2026-12-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 69 participants in total. It began in 2024-04-11 with a primary completion date of 2026-12-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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...)
Contact & Investigator
Cécile Goujard, Pr
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT05300035 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying HIV/AIDS and Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05300035 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05300035 currently recruiting?
Yes, NCT05300035 is actively recruiting participants. Contact the research team at mathilde.ghislain@inserm.fr for enrollment information.
Where is the NCT05300035 trial being conducted?
This trial is being conducted at Bobigny, France, Clamart, France, Clichy, France, Créteil, France and 11 additional locations.
Who is sponsoring the NCT05300035 clinical trial?
NCT05300035 is sponsored by ANRS, Emerging Infectious Diseases. The principal investigator is Cécile Goujard, Pr at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 69 participants.
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