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Title: Preserved central nervous system functioning after use of romidepsin as a latency-reversing agent in an HIV cure strategy
Author: Muñoz Moreno, Jose Antonio
Carrillo Molina, Sara
Martínez Zalacaín, Ignacio
Miranda, Cristina
Manzardo, Christian
Coll, Pep
Meulbroek, Michael
Hanke, Tomáš
Garolera, Maite  
Miró, Josep M.
Brander, Christian
Clotet, Bonaventura
Soriano Mas, Carles
Moltó, José
Mothe, Beatriz
BCN02-Neuro Substudy Group
Others: Fundació Lluita contra la SIDA
Hospital Universitari Germans Trias i Pujol
Universitat Oberta de Catalunya. Estudis de Psicologia i Ciències de l'Educació
Institut d'Investigació Biomèdica de Bellvitge (IDIBELL)
Universitat de Barcelona
Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)
Projecte dels NOMS-Hispanosida
Institut de Recerca de la Sida (IrsiCaixa)
University of Oxford
Kumamoto University
Consorci Sanitari de Terrassa
Universitat de Vic - Universitat Central de Catalunya
Institució Catalana de Recerca i Estudis Avançats (ICREA)
Instituto de Salud Carlos III
Universitat Autònoma de Barcelona
Keywords: central nervous system
histone deacetylase inhibitors
HIV infection
kick&kill strategies
Issue Date: 1-Mar-2022
Publisher: AIDS
Citation: Muñoz-Moreno, J.A., Carrillo-Molina, S., Martínez-Zalacaín, I., Miranda, C., Manzardo, C., Coll, P., Meulbroek, M., Hanke, T., Garolera, M., Miró, J.M., Brander, C., Clotet, B., Soriano-Mas, C., Moltó, J. & Mothe, B. (2022). Preserved central nervous system functioning after use of romidepsin as a latency-reversing agent in an HIV cure strategy. AIDS, 36(3), 363-372. doi: 10.1097/QAD.0000000000003121
Published in: 36;3
Project identifier: info:eu-repo/grantAgreement/ISCIII/PI15-01188
Also see:
Abstract: Objective: To assess the central nervous system (CNS) impact of a kick&kill HIV cure strategy using therapeutic vaccine MVA.HIVconsv and the histone deacetylase inhibitor (HDACi) romidepsin (RMD) as latency-reversing agent. Design: Neurological observational substudy of the BCN02 trial (NCT02616874), a proof-of-concept, open-label, single-arm, phase I clinical trial testing the safety and immunogenicity of the MVA.HIVconsv vaccine and RMD in early-treated HIV-1-infected individuals. A monitored antiretroviral pause (MAP) was performed, with cART resumption after 2 pVL more than 2000 copies/ml. Reinitiated participants were followed for 24 weeks. Methods: Substudy participation was offered to all BCN02 participants (N = 15). Evaluations covered cognitive, functional, and brain imaging outcomes, performed before RMD administration (pre-RMD), after three RMD infusions (post-RMD), and at the end of the study (EoS). A group of early-treated HIV-1-infected individuals with matched clinical characteristics was additionally recruited (n = 10). Primary endpoint was change in a global cognitive score (NPZ-6). Results: Eleven participants from BCN02 trial were enrolled. No significant changes were observed in cognitive, functional, or brain imaging outcomes from pre-RMD to post-RMD. No relevant alterations were detected from pre-RMD to EoS either. Scores at EoS were similar in participants off cART for 32 weeks (n = 3) and those who resumed therapy for 24 weeks (n = 7). Controls showed comparable punctuations in NPZ-6 across all timepoints. Conclusion: No detrimental effects on cognitive status, functional outcomes, or brain imaging parameters were observed after using the HDACi RMD as latency-reversing agent with the MVA.HIVconsv vaccine in early-treated HIV-1-infected individuals. CNS safety was also confirmed after completion of the MAP.
Language: English
ISSN: 0269-9370MIAR
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