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

NCT03163277 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2020-11-06

No results posted yet for this study

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.

Conditions

  • Hiv
  • Neurocognitive Dysfunction

Interventions

DRUG

emtricitabine, darunavir/cobicistat, maraviroc

Treatment change

Sponsors & Collaborators

  • Giovanni Di Perri

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-15
Primary Completion
2020-06-30
Completion
2020-06-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03163277 on ClinicalTrials.gov