Using Less Neurotoxic Drugs in Patients With HAND (MARAND-X)

Summary

Neurocognitive disorders are still highly prevalent in the HAART era; despite a dramatic reduction in dementia cases, 15-50% of patients may develop mild or asymptomatic neurocognitive disorders (HIV-associated neurocognitive disorders, HAND). Among other hypothesis neurotoxicity of antiretrovirals has been postulated but its impact is unknown. Our hypothesis is that using drugs with reduced in vitro neurotoxicity may improve cognition in HIV-positive patients withHAND. 76 patients with HAND will be randomized to either continue their treatment or switch to emtricitabine, darunavir/cobicistat, maraviroc. Patients will be re-tested 6 months later.

Timeline

Start

2017-05-15

Primary completion

2020-06-30

Completion

2020-06-30

Outcome

Outcome not reported

Stopped (Enrollment): “Sloww accrual and COVID-19 related problems (impossible to perform LPs)”

Publications

• Stroffolini G, Lazzaro A, Barco A, Pirriatore V, Vai D, Giaccone C, Nigra M, Atzori C, Trunfio M, Bonora S, Di Perri G G, Calcagno A. Changes in Cerebrospinal Fluid, Liver and Intima-media-thickness Biomarkers in Patients with HIV-associated Neurocognitive Disorders Randomized to a Less Neurotoxic Treatment Regimen. J Neuroimmune Pharmacol. 2023 Dec;18(4):551-562. doi: 10.1007/s11481-023-10086-7. Epub 2023 Oct 31.

Drugs

Indications