RIO is a placebo-controlled double-blinded two arm prospective phase II randomised controlled trial . This study will test the use of broadly neutralising antibodies (bNAbs) in participants with treated primary HIV infection (PHI).
This study proposes a trial of a novel combination of long-acting broadly neutralising antibodies in participants initiating ART early after HIV acquisition, during primary HIV infection (PHI). The aim of this study is to investigate the effect of dual long-acting versions of bNABs (3BNC117-LS and 10-1074-LS) in a randomised clinical trial powered to answer the question whether these bNAbs are effective at controlling HIV replication in the absence of ART. The study aims to enrol 72 individuals across multiple UK collaborating clinical centres. Participants will have been previously diagnosed with primary HIV-1 infection, will have started ART during early phase of Primary HIV infection, and who have remained on suppressive ART without interruption for at least 12 months. Study duration will vary by participant, depending on the time to viral rebound. The results from this trial will demonstrate whether or not the combination of two long-acting (LS) broadly neutralising antibodies, 3BNC117-LS and 10-1074-LS, will prevent HIV viral rebound after stopping antiretroviral therapy for an extended period of time in adults living with HIV who initiated ART during early HIV infection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
72
Recombinant human monoclonal antibody (mAb) or placebo
Aarhus University Hospital
Aarhus, Denmark
RECRUITINGUniversity Hospitals Sussex NHS Foundation Trust
Brighton, United Kingdom
RECRUITINGTime to viral rebound within 20 weeks after initial ATI
Virological control will be assessed in participants infused with broadly neutralising antibodies compared to placebo.
Time frame: up to 20 weeks
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Western General Hospital
Edinburgh, United Kingdom
RECRUITINGImperial College NHS Healthcare Trust
London, United Kingdom
RECRUITINGBarts Health NHS Trust
London, United Kingdom
RECRUITINGChelsea And Westminster Hospital NHS Foundation Trust
London, United Kingdom
RECRUITINGGuy's and St Thomas' NHS Foundation Trust
London, United Kingdom
RECRUITINGMortimer Market CNWL Hospital NHS Foundation Trust
London, United Kingdom
RECRUITINGRoyal Free London NHS Foundation Trust
London, United Kingdom
RECRUITINGSt Georges Hospital NHS Foundation Trust
London, United Kingdom
RECRUITING...and 2 more locations