drugset / Trial / NCT03163277

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

NCT03163277

Phase 4 Terminated 38 enrolled Giovanni Di Perri
RandomizedParallel-groupOpen-labelTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Cobicistat Small molecule 150 mg
Subject Darunavir Small molecule 800 mg
Subject Maraviroc Other / unclassified 300 mg
Subject emtricitabine Other / unclassified 200 mg