WISARD (NEAT33) - Switch Study Mutation Ripivirine Dolutegravir
An open-label, multicentre, randomised, switch study to evaluate the virological efficacy over 96 weeks of 2-drug therapy with DTG/RPV FDC in antiretroviral treatment-experienced HIV-1 infected subjects virologically suppressed with NNRTIs resistance mutation K103N
Status: Ongoing (closed to recruitment)
Sponsor number: SSCR105/NEAT33
EudraCT: 2017-004040-38
Sponsor: NEAT ID
Phase: IIIb
Indication: HIV-1 infected patients with a history of virological failure to NNRTIs and having the K103N mutation
Countries: UK, France, Germany, Belgium, Spain, Italy, Ireland
Sites: 36 activated sites
Territories : 7
Posters:
E-poster at IAS 2021
Title : 24 WEEK RANDOMISED STUDY OF SWITCH TO DTG/RPV IN SUBJECTS WITH HIV RNA <50C/ML AND ARCHIVED K103N
Authors : Graeme Moyle1, Lambert Assoumou2, Jean-Michel Molina3, Frank A. Post4, AdriàCurran5, Stefano Rusconi6, Stephane De Wit7, Christoph Stephan8, François Raffi9, Margaret Johnson10, Maria Del Mar Masia11, Jaime Vera12, Jacob Lowman13, Anton Pozniak14, for NEAT Foundation, WISARD study group1Chelsea
E-poster at AIDS 2022
Title : Randomised study of switch to DTG/RPV in subjects with HIV RNA <50c/ml and archived K103N over 48 weeks
Authors : Graeme Moyle1, Lambert Assoumou2, Jean-Michel Molina3, FrankPost4, AdriàCurran5, Stefano Rusconi6, Stephane De Wit7, Christoph Stephan8, François Raffi9, Margaret Johnson10, Maria Del Mar Masia11, Jamie Vera12, Carl Fletcher13, Annie Duffy13, Kellie Morris13, Anton Pozniak1, for NEAT Foundation, WISARD study group.
Poster at IAS 2024
Title : E5 of a randomised switch to DTG/RPV in subjects with HIV RNA <50c/ml and archived K103N (Wisard study): Week 96 results
Authors : Graeme Moyle1, Lambert Assoumou2, Jean Michel Molina3, Fran Post4, Adrià Curran5, Stefano Rusconi6, Stephane De Wit7 ,Christoph Stephan8, François Raffi9, Margaret Johnson10, Mar Masia11, Jamie Vera12, Bryn Jones13, CarlFletcher 14, KellieMorris 14, Anton Pozniak 1, NEAT Foundation, WISARDstudygroup.
Paper - Lancet HIV
Title : Switching to dolutegravir plus rilpivirine versus maintaining current antiretroviral therapy regimen in virologically suppressed people with HIV-1 and the Lys103Asn (K103N) mutation: 48-week results from a randomised, open-label pilot clinical trial
Author : Graeme Moyle, Lambert Assoumou, Nathalie de Castro, Frank A Post, Adrian Curran, Stefano Rusconi, Stephane De Wit, Christoph Stephan, François Raffi, Margaret Johnson, Mar Masia, Jaime Vera, Bryn Jones, Richard Grove, Carl Fletcher, Annie Duffy, Kellie Morris, Anton Pozniak, for NEAT ID Foundation and the WISARD study group
