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Switching to Low Neurotoxic Antiretrovirals to Improve Neurocognition Among People Living With HIV-1-Associated Neurocognitive Disorder: The MARAND-X Randomized Clinical Trial.
Lazzaro, Alessandro; Vai, Daniela; Barco, Ambra; Stroffolini, Giacomo; Pirriatore, Veronica; Guastamacchia, Giulia; Nigra, Marco; Ghisetti, Valeria; Tettoni, Maria Cristina; Noce, Giuseppe; Giaccone, Claudia; Trunfio, Mattia; Trentalange, Alice; Bonora, Stefano; Di Perri, Giovanni; Calcagno, Andrea.
Afiliação
  • Lazzaro A; Department of Public Health and Infectious Diseases, Sapienza University of Rome, Policlinico Umberto I of Rome, Rome, Italy.
  • Vai D; Unit of Neurology, Maria Vittoria Hospital, ASL Città di Torino, Turin, Italy.
  • Barco A; Infectious Diseases Unit, Ospedale Maggiore della Carità, Novara, Italy.
  • Stroffolini G; Department of Medical Sciences, Unit of Infectious Diseases, University of Turin, Turin, Italy.
  • Pirriatore V; Department of Infectious-Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar, Italy.
  • Guastamacchia G; SC Tropical and Infectious Disease, ASL Città di Torino, Turin, Italy.
  • Nigra M; Unit of Neurology, Maria Vittoria Hospital, ASL Città di Torino, Turin, Italy.
  • Ghisetti V; Biochemistry and Immunology Laboratory, Maria Vittoria Hospital, ASL "Città di Torino", Turin, Italy.
  • Tettoni MC; Microbiology and Molecular Biology Laboratory, Amedeo di Savoia Hospital, ASL Città di Torino, Turin, Italy; and.
  • Noce G; Department of Medical Sciences, Unit of Infectious Diseases, University of Turin, Turin, Italy.
  • Giaccone C; IRCCS Synlab SDN, Naples, Italy.
  • Trunfio M; Unit of Neurology, Maria Vittoria Hospital, ASL Città di Torino, Turin, Italy.
  • Trentalange A; Department of Medical Sciences, Unit of Infectious Diseases, University of Turin, Turin, Italy.
  • Bonora S; Department of Medical Sciences, Unit of Infectious Diseases, University of Turin, Turin, Italy.
  • Di Perri G; Department of Medical Sciences, Unit of Infectious Diseases, University of Turin, Turin, Italy.
  • Calcagno A; Department of Medical Sciences, Unit of Infectious Diseases, University of Turin, Turin, Italy.
J Acquir Immune Defic Syndr ; 97(2): 180-191, 2024 Oct 01.
Article em En | MEDLINE | ID: mdl-39250652
ABSTRACT

BACKGROUND:

The pathogenesis of HIV-associated neurocognitive (NC) impairment is multifactorial, and antiretroviral (ARV) neurotoxicity may contribute. However, interventional pharmacological studies are limited.

METHODS:

Single-blind, randomized (11), controlled trial to assess the change of NC performance (Global Deficit Score, GDS, and domain scores) in PLWH with NC impairment randomized to continue their standard of care treatment or to switch to a less neurotoxic ARV regimen darunavir/cobicistat, maraviroc, emtricitabine (MARAND-X). Participants had plasma and cerebrospinal fluid HIV RNA< 50 copies/mL, R5-tropic HIV, and were on ARV regimens that did not include efavirenz and darunavir. The change of resting-state electroencephalography was also evaluated. The outcomes were assessed at week 24 of the intervention through tests for longitudinal paired data and mixed-effect models.

RESULTS:

Thirty-eight participants were enrolled and 28 completed the follow-up. Global Deficit Score improved over time but with no difference between arms in longitudinal adjusted models. Perceptual functions improved in the MARAND-X, while long-term memory improved only in participants within the MARAND-X for whom the central nervous system penetration-effectiveness (CNS penetration effectiveness) score increased by ≥3. No significant changes in resting-state electroencephalography were observed.

CONCLUSIONS:

In this small but well-controlled study, the use of less neurotoxic ARV showed no major beneficial effect over an unchanged regimen. The beneficial effects on the memory domain of increasing CNS penetration effectiveness score suggest that ARV neuropenetration may have a role in cognitive function.
Assuntos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Infecções por HIV / Fármacos Anti-HIV Limite: Adult / Female / Humans / Male / Middle aged Idioma: En Revista: J Acquir Immune Defic Syndr Assunto da revista: SINDROME DA IMUNODEFICIENCIA ADQUIRIDA (AIDS) Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Itália País de publicação: Estados Unidos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Infecções por HIV / Fármacos Anti-HIV Limite: Adult / Female / Humans / Male / Middle aged Idioma: En Revista: J Acquir Immune Defic Syndr Assunto da revista: SINDROME DA IMUNODEFICIENCIA ADQUIRIDA (AIDS) Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Itália País de publicação: Estados Unidos