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New treatment option for HIV/AIDS and Infections
Official title Phase II Trial of ART + Dual bNAbs vs. ART + Placebo During Primary HIV-1 Infection-impact on Post-ART Control
ClinicalTrials.gov ID: NCT05300035
What this study is testing
What is Recombinant human monoclonal antibody (bNAbs)?
Recombinant human monoclonal antibody (bNAbs) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hiv/aids and infections.
Also referred to as 10-1074-LS and 3BNC117-LS.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
You likely can't join if
- Participation in any other clinical trial requiring additional blood sampling Participation in an observational study without additional blood...
- 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...
- Current or past history of cancer, excluding squamous cell skin cancers
See the full eligibility 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
- 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...)
The study team makes the final eligibility decision.
Where it's taking place
- Bobigny, France
- Clamart, France
- Clichy, France
- Créteil, France
- Garches, France
- Le Kremlin-Bicêtre, France
- Paris, France
- Suresnes, France
- Villeneuve-Saint-Georges, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bobigny, France; Clamart, France; Clichy, France; Créteil, France; Garches, France; Le Kremlin-Bicêtre, France and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.