Status:
RECRUITING
Phase II Trial of ART + Dual bNAbs vs. ART + Placebo During Primary HIV-1 Infection-impact on Post-ART Control
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Collaborating Sponsors:
Rockefeller University
Institut Pasteur
Conditions:
HIV/AIDS and Infections
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 inf...
Detailed Description
The study proposes to test an intervention consisting of dual long-acting HIV-specific broadly neutralizing antibodies (3BNC117-LS \& 10-1074-LS ) + ART, at primary HIV-1 infection, and to compare it ...
Eligibility Criteria
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
- 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...)
Key Trial Info
Start Date :
April 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 10 2028
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT05300035
Start Date
April 11 2024
End Date
December 10 2028
Last Update
December 27 2024
Active Locations (17)
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1
Hôpial Avicenne - SMIT
Bobigny, France, 93000
2
Hôpital Antoine Béclère
Clamart, France, 92140
3
Hôpital Beaujon - Service de médecine interne
Clichy, France, 92110
4
CHI Créteil - HdJ
Créteil, France, 94010