Safety and Effectiveness of the Selegiline "Patch" for Decreased Mental Function in HIV Patients
NCT ID: NCT00013585
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
127 participants
INTERVENTIONAL
2005-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This is a two-step study, with each step lasting 24 weeks. Step 1 is double-blind and Step 2 is open label. At entry, patients are randomly assigned to receive either the STS or placebo. One STS patch will be applied daily at the same time for 24 weeks. Patients are evaluated at the clinic at entry and at Weeks 2, 4, 8, 12, 16, and 24. Cognitive status will be evaluated by performance on a series of neuropsychological assessments. Patients who complete Step 1 may participate in Step 2. Patients on placebo in Step 1 will receive active STS treatment in Step 2. The STS patch is applied once daily for an additional 24 weeks and patients are evaluated at the clinic at Weeks 28, 36, and 48.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Selegiline hydrochloride
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Stable anti-HIV therapy or no anti-HIV therapy for at least 8 weeks prior to study screening
* AIDS Dementia Complex Stage of greater than 0
* Decreased mental function as shown by tests during screening
* IQ of 70 or greater
* Willing to use acceptable methods of contraception during study and for 3 months following study
Exclusion Criteria
* Serious mental illness that, in the opinion of the investigator, might interfere with the study
* Reserpine or meperidine within 7 days prior to study entry
* Nefazodone within 14 days prior to study entry
* Monoamine oxidase inhibitor, including selegiline, within 30 days prior to study entry
* Sympathomimetic medications, including over the counter diet and cold (oral or nasal) remedies, within 14 days of study entry
* Decreased blood pressure when standing up
* Uncontrolled high blood pressure
* Active symptomatic AIDS-defining opportunistic infection within 30 days prior to study entry
* Nervous system disorders such as multiple sclerosis, stroke, serious head injury, uncontrolled epilepsy, Tourette's syndrome, Huntington's disease, dementias due to alcohol abuse, vitamin B12 deficiency, or syphilis
* CNS infections or neoplasms including cytomegalovirus (CMV) encephalitis, toxoplasmosis, primary or metastatic CNS lymphoma, progressive multifocal leukoencephalopathy, cryptococcal or other fungal meningitis, tuberculous CNS infection, or untreated neurosyphilis
* Any other condition that, in the investigator's opinion, would interfere with the study
* Certain investigational drugs within 30 days before study entry
* Allergic to selegiline or the STS patch
* Pregnant or breastfeeding
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Neurologic AIDS Research Consortium (NARC)
OTHER
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Giovanni Schifitto, M.D.
Role: STUDY_CHAIR
Department of Neurology, University of Rochester Medical Center
Ned Sacktor, M.D.
Role: STUDY_CHAIR
Department of Neurology, Johns Hopkins University Bayview Medical Center
David Simpson, M.D.
Role: STUDY_CHAIR
Department of Clinical Neurophysiology, Mount Sinai School of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UCLA CARE Center CRS
Los Angeles, California, United States
Ucsd, Avrc Crs
San Diego, California, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, United States
Northwestern University CRS
Chicago, Illinois, United States
Cook County Hosp. CORE Ctr.
Chicago, Illinois, United States
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, United States
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, United States
Washington U CRS
St Louis, Missouri, United States
Beth Israel Med. Ctr., ACTU
New York, New York, United States
Columbia Univ., HIV Prevention and Treatment Medical Ctr.
New York, New York, United States
Univ. of Rochester ACTG CRS
Rochester, New York, United States
Unc Aids Crs
Chapel Hill, North Carolina, United States
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, United States
The Miriam Hosp. ACTG CRS
Providence, Rhode Island, United States
University of Washington AIDS CRS
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Bell JE. An update on the neuropathology of HIV in the HAART era. Histopathology. 2004 Dec;45(6):549-59. doi: 10.1111/j.1365-2559.2004.02004.x.
Koutsilieri E, Scheller C, ter Meulen V, Riederer P. Monoamine oxidase inhibition and CNS immunodeficiency infection. Neurotoxicology. 2004 Jan;25(1-2):267-70. doi: 10.1016/S0161-813X(03)00105-0.
McArthur JC. HIV dementia: an evolving disease. J Neuroimmunol. 2004 Dec;157(1-2):3-10. doi: 10.1016/j.jneuroim.2004.08.042.
Sacktor N, Schifitto G, McDermott MP, Marder K, McArthur JC, Kieburtz K. Transdermal selegiline in HIV-associated cognitive impairment: pilot, placebo-controlled study. Neurology. 2000 Jan 11;54(1):233-5. doi: 10.1212/wnl.54.1.233.
Schifitto G, Kieburtz K, McDermott MP, McArthur J, Marder K, Sacktor N, Palumbo D, Selnes O, Stern Y, Epstein L, Albert S. Clinical trials in HIV-associated cognitive impairment: cognitive and functional outcomes. Neurology. 2001 Feb 13;56(3):415-8. doi: 10.1212/wnl.56.3.415.
Evans SR, Yeh TM, Sacktor N, Clifford DB, Simpson D, Miller EN, Ellis RJ, Valcour V, Marra CM, Millar L, Schifitto G; AIDS Clinical Trials Group and the Neurologic AIDS Research Consortium. Selegiline transdermal system (STS) for HIV-associated cognitive impairment: open-label report of ACTG 5090. HIV Clin Trials. 2007 Nov-Dec;8(6):437-46. doi: 10.1310/hct0806-437.
Schifitto G, Deng L, Yeh TM, Evans SR, Ernst T, Zhong J, Clifford D. Clinical, laboratory, and neuroimaging characteristics of fatigue in HIV-infected individuals. J Neurovirol. 2011 Feb;17(1):17-25. doi: 10.1007/s13365-010-0010-5. Epub 2010 Dec 23.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
10075
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG A5090
Identifier Type: -
Identifier Source: secondary_id
AACTG A5090
Identifier Type: -
Identifier Source: secondary_id
A5090
Identifier Type: -
Identifier Source: org_study_id