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Safety and Effectiveness of the Selegiline "Patch" for Decreased Mental Function in HIV Patients

NCT00013585 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2021-11-01

No results posted yet for this study

Summary

A decrease in mental function often occurs in patients with HIV. Antiretroviral (ARV) drugs are used to treat this but are not entirely effective. Some other therapy could play a role. The drug selegiline in its pill form is used to treat Parkinson's disease, a serious brain disorder. It is believed this drug might protect the brain and repair some damage. This study will use this drug in a "patch" form, which has not been approved by the Food and Drug Administration (FDA), to see if it helps with decreased mental function in patients with HIV. The purpose of this study is to evaluate the use of selegiline transdermal system (STS) in the treatment of decreased mental function in patients with HIV.

Conditions

  • Cognition Disorders
  • HIV Infections

Interventions

DRUG

Selegiline hydrochloride

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Neurologic AIDS Research Consortium (NARC)

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Giovanni Schifitto, M.D. · Department of Neurology, University of Rochester Medical Center

  • Ned Sacktor, M.D. · Department of Neurology, Johns Hopkins University Bayview Medical Center

  • David Simpson, M.D. · Department of Clinical Neurophysiology, Mount Sinai School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Completion
2005-12-31

Countries

  • United States

Study Locations

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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 NCT00013585 on ClinicalTrials.gov