Actively Recruiting
Phase II Trial of ART + Dual bNAbs vs. ART + Placebo During Primary HIV-1 Infection-impact on Post-ART Control
Led by ANRS, Emerging Infectious Diseases · Updated on 2024-12-27
69
Participants Needed
17
Research Sites
243 weeks
Total Duration
On this page
Sponsors
A
ANRS, Emerging Infectious Diseases
Lead Sponsor
R
Rockefeller University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase II Trial of ART + Dual bNAbs vs. ART + Placebo During Primary HIV-1 Infection-impact on Post-ART Control
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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...)
AI-Screening
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Trial Site Locations
Total: 17 locations
1
Hôpial Avicenne - SMIT
Bobigny, France, 93000
Actively Recruiting
2
Hôpital Antoine Béclère
Clamart, France, 92140
Actively Recruiting
3
Hôpital Beaujon - Service de médecine interne
Clichy, France, 92110
Actively Recruiting
4
CHI Créteil - HdJ
Créteil, France, 94010
Actively Recruiting
5
Hôpital Raymond Poincaré - SMIT
Garches, France, 92380
Actively Recruiting
6
Hôpital Bicêtre - HdJ - Médecine interne
Le Kremlin-Bicêtre, France, 94275
Actively Recruiting
7
Hôpital Hôtel - Dieu
Paris, France, 75004
Actively Recruiting
8
Hôpital Hôtel Dieu - Service d'immunologie clinique
Paris, France, 75004
Not Yet Recruiting
9
Hôpital Pitié-Salpêtrière - SMIT
Paris, France, 75013
Actively Recruiting
10
Hôpital Lariboisière - Service de médecine interne A
Paris, France, 75475
Actively Recruiting
11
Hôpital Saint- Louis - SMIT
Paris, France, 75475
Actively Recruiting
12
Hôpital Saint-Antoine - SMIT
Paris, France, 75571
Actively Recruiting
13
Hôpital Necker - SMIT
Paris, France, 75743
Actively Recruiting
14
Hôpital Bichat - Claude Bernard - SMIT
Paris, France, 75877
Actively Recruiting
15
Hôpital Tenon - SMIT
Paris, France, 75970
Actively Recruiting
16
Centre médico chirurgical Foch - Suresnes
Suresnes, France, 92151
Actively Recruiting
17
CHI Villeneuve-Saint-Georges - SMIT
Villeneuve-Saint-Georges, France, 94195
Actively Recruiting
Research Team
M
Mathilde Ghislain, MSc
CONTACT
N
Nicolas Leturque, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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