Imperial College London
Ms Emanuela Falaschetti

MsEmanuelaFalaschetti

Faculty of Medicine, School of Public Health

Deputy Head of Statistics
 
 
 
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Contact

 

+44 (0)20 7594 1846e.falaschetti

 
 
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Location

 

Stadium HouseWhite City Campus

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Summary

 

Publications

Citation

BibTex format

@article{Lee:2022:10.1186/s13063-022-06151-w,
author = {Lee, MJ and Collins, S and Babalis, D and Johnson, N and Falaschetti, E and Prevost, AT and Ashraf, A and Jacob, M and Cole, T and Hurley, L and Pace, M and Ogbe, A and Khan, M and Zacharopoulou, P and Brown, H and Sutherland, E and Box, H and Fox, J and Deeks, S and Horowitz, J and Nussenzweig, MC and Caskey, M and Frater, J and Fidler, S},
doi = {10.1186/s13063-022-06151-w},
journal = {Trials},
title = {The RIO trial: rationale, design, and the role of community involvement in a randomised placebo-controlled trial of antiretroviral therapy plus dual long-acting HIV-specific broadly neutralising antibodies (bNAbs) in participants diagnosed with recent HIV infection-study protocol for a two-stage randomised phase II trial},
url = {http://dx.doi.org/10.1186/s13063-022-06151-w},
volume = {23},
year = {2022}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - Background:Antiretroviral therapy (ART) has led to dramatic improvements in survival for people living with HIV, but is unable to cure infection, or induce viral control off therapy. Designing intervention trials with novel agents with the potential to confer a period of HIV remission without ART remains a key scientific and community goal. We detail the rationale, design, and outcomes of a randomised, placebo-controlled trial of two HIV-specific long-acting broadly neutralising antibodies (bNAbs): 3BNC117-LS and 10-1074-LS, which target CD4 binding site and V3 loop respectively, on post-treatment viral control.Methods:RIO is a randomised, placebo-controlled, double-blinded prospective phase II study. Eligible individuals will have started ART within 3 months of primary HIV infection and have viral sequences that appear to be sensitive to both bNAbs. It will randomise 72 eligible participants 1:1 to the following arms via a two-stage design. In Stage 1, arm A participants are given dual long-acting (LS-variants) bNAbs infusions, followed by intensively monitored Analytical Treatment Interruption (ATI) (n = 36); in arm B, participants receive placebo infusions followed by ATI. The primary endpoint will be time to viral rebound within 36 weeks after ATI. Upon viral rebound, the participant and researcher are unblinded. Participants in arm A recommence ART and complete the study. Participants in arm B are invited to restart ART and enroll into Stage 2 where they will receive open-label LS bNAbs, followed by a second ATI 24 weeks after. Secondary and exploratory endpoints include adverse events, time to undetectable viraemia after restarting ART, immunological markers, HIV proviral DNA, serum bNAb concentrations in blood, bNAb resistance at viral rebound, and quality of life measures.Discussion:The two-stage design was determined in collaboration with community involvement. This design allows all participants the option to receive bNAbs. It also tes
AU  - Lee,MJ
AU  - Collins,S
AU  - Babalis,D
AU  - Johnson,N
AU  - Falaschetti,E
AU  - Prevost,AT
AU  - Ashraf,A
AU  - Jacob,M
AU  - Cole,T
AU  - Hurley,L
AU  - Pace,M
AU  - Ogbe,A
AU  - Khan,M
AU  - Zacharopoulou,P
AU  - Brown,H
AU  - Sutherland,E
AU  - Box,H
AU  - Fox,J
AU  - Deeks,S
AU  - Horowitz,J
AU  - Nussenzweig,MC
AU  - Caskey,M
AU  - Frater,J
AU  - Fidler,S
DO  - 10.1186/s13063-022-06151-w
PY  - 2022///
SN  - 1745-6215
TI  - The RIO trial: rationale, design, and the role of community involvement in a randomised placebo-controlled trial of antiretroviral therapy plus dual long-acting HIV-specific broadly neutralising antibodies (bNAbs) in participants diagnosed with recent HIV infection-study protocol for a two-stage randomised phase II trial
T2  - Trials
UR  - http://dx.doi.org/10.1186/s13063-022-06151-w
UR  - http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000778488100002&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=1ba7043ffcc86c417c072aa74d649202
UR  - http://hdl.handle.net/10044/1/96608
VL  - 23
ER  -
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