Phase II Trial of ART + Dual bNAbs vs. ART + Placebo During Primary HIV-1 Infection-impact on Post-ART Control
RHIVIERA-02
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.
1 other identifier
interventional
69
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2024
Longer than P75 for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 3, 2022
CompletedFirst Posted
Study publicly available on registry
March 29, 2022
CompletedStudy Start
First participant enrolled
April 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 10, 2028
December 27, 2024
December 1, 2024
2.7 years
January 3, 2022
December 23, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of participants with plasma HIV-1 RNA below 400 cp/mL 24 weeks following ATI (W24 ATI), in the confirmed absence of ART.
These participants will be considered as post-treatment controllers.
at Week 24 of antiretroviral treatment interruption period (ATI)
Secondary Outcomes (22)
Tolerance of bNAbs infusion : Number of clinical and biological adverse event (AE)
from date of inclusion to the last follow-up visit date, up to 148 weeks
Tolerance of bNAbs infusion : Nature and Grade of clinical and biological AE
from date of inclusion to the last follow-up visit date, up to 148 weeks
Tolerance of bNAbs infusion : Time of clinical and biological adverse event (AE)
from date of inclusion to the last follow-up visit date, up to 148 weeks
Proportion of participants resuming ART within the first 24 weeks of ART interruption, according to the reason for resuming.
at Week 24 of antiretroviral treatment interruption period (ATI)
Time to potential ART resumption for non-controllers.
from Day 0 of antiretroviral treatment interruption period (ATI) to Day 0 of ART resumption date, assessed up to 48 weeks following ATI
- +17 more secondary outcomes
Study Arms (2)
bNAbs
ACTIVE COMPARATORART plus dual long-acting (LS) broadly neutralising antibodies (bNAbs) infusion at HIV-1 primary HIV-1 infection, during 52 weeks minimum, followed by and Antiretroviral Treatment Interruption (ATI).
Placebo
PLACEBO COMPARATORART plus placebo (saline solution) at HIV-1 primary HIV-1 infection, during 52 weeks minimum, followed by and Antiretroviral Treatment Interruption (ATI).
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Confirmed primary HIV-1 infection diagnostic
- Aged ≥18 to ≤70 years old at screening
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ANRS, Emerging Infectious Diseaseslead
- Rockefeller Universitycollaborator
- Institut Pasteurcollaborator
Study Sites (17)
Hôpial Avicenne - SMIT
Bobigny, 93000, France
Hôpital Antoine Béclère
Clamart, 92140, France
Hôpital Beaujon - Service de médecine interne
Clichy, 92110, France
CHI Créteil - HdJ
Créteil, 94010, France
Hôpital Raymond Poincaré - SMIT
Garches, 92380, France
Hôpital Bicêtre - HdJ - Médecine interne
Le Kremlin-Bicêtre, 94275, France
Hôpital Hôtel - Dieu
Paris, 75004, France
Hôpital Hôtel Dieu - Service d'immunologie clinique
Paris, 75004, France
Hôpital Pitié-Salpêtrière - SMIT
Paris, 75013, France
Hôpital Lariboisière - Service de médecine interne A
Paris, 75475, France
Hôpital Saint- Louis - SMIT
Paris, 75475, France
Hôpital Saint-Antoine - SMIT
Paris, 75571, France
Hôpital Necker - SMIT
Paris, 75743, France
Hôpital Bichat - Claude Bernard - SMIT
Paris, 75877, France
Hôpital Tenon - SMIT
Paris, 75970, France
Centre médico chirurgical Foch - Suresnes
Suresnes, 92151, France
CHI Villeneuve-Saint-Georges - SMIT
Villeneuve-Saint-Georges, 94195, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cécile Goujard, Pr
Assistance Publique - Hôpitaux de Paris
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2022
First Posted
March 29, 2022
Study Start
April 11, 2024
Primary Completion (Estimated)
December 10, 2026
Study Completion (Estimated)
December 10, 2028
Last Updated
December 27, 2024
Record last verified: 2024-12