Safety and Effectiveness of the Selegiline "Patch" for Decreased Mental Function in HIV Patients
Phase II, Placebo-Controlled, Double-Blind Study of the Selegiline Transdermal System (STS) in the Treatment of HIV-Associated Cognitive Impairment
4 other identifiers
interventional
127
1 country
15
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2001
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedNovember 1, 2021
October 1, 2021
March 22, 2001
October 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in cognitive performance Week 24 from screening
frequencies of adverse experiences, abnormal results on laboratory tests, changes over time in laboratory tests and vital signs
Secondary Outcomes (9)
Clinical global impression by the investigator comparing selegiline-treated arms with the placebo arm
clinical global impression by the subject comparing selegiline-treated arms with the placebo arm
cognitive domain-specific scores compared between selegiline-treated arms and the placebo arm
neuropsychologic function tests (NPZ-8)
fatigue scale (quality of life)
- +4 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- HIV infected
- 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
You may not qualify if:
- Tumor involving a large organ or requiring chemotherapy. Patients with basal cell carcinoma, in situ carcinoma of the cervix, or Kaposi's sarcoma are not excluded.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
UCLA CARE Center CRS
Los Angeles, California, 90095, United States
Ucsd, Avrc Crs
San Diego, California, 92103, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, 96816, United States
Northwestern University CRS
Chicago, Illinois, 60611, United States
Cook County Hosp. CORE Ctr.
Chicago, Illinois, 60612, United States
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, 02114, United States
Washington U CRS
St Louis, Missouri, United States
Beth Israel Med. Ctr., ACTU
New York, New York, 10003, United States
Columbia Univ., HIV Prevention and Treatment Medical Ctr.
New York, New York, 10032, United States
Univ. of Rochester ACTG CRS
Rochester, New York, 14642, United States
Unc Aids Crs
Chapel Hill, North Carolina, 27514, United States
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, 19104, United States
The Miriam Hosp. ACTG CRS
Providence, Rhode Island, 02906, United States
University of Washington AIDS CRS
Seattle, Washington, 98104, United States
Related Publications (7)
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.
PMID: 15569045BACKGROUNDKoutsilieri 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.
PMID: 14697901BACKGROUNDMcArthur JC. HIV dementia: an evolving disease. J Neuroimmunol. 2004 Dec;157(1-2):3-10. doi: 10.1016/j.jneuroim.2004.08.042.
PMID: 15579274BACKGROUNDSacktor 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.
PMID: 10636157BACKGROUNDSchifitto 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.
PMID: 11171916BACKGROUNDEvans 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.
PMID: 18042509RESULTSchifitto 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.
PMID: 21181521RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Giovanni Schifitto, M.D.
Department of Neurology, University of Rochester Medical Center
- STUDY CHAIR
Ned Sacktor, M.D.
Department of Neurology, Johns Hopkins University Bayview Medical Center
- STUDY CHAIR
David Simpson, M.D.
Department of Clinical Neurophysiology, Mount Sinai School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2001
First Posted
August 31, 2001
Study Completion
December 1, 2005
Last Updated
November 1, 2021
Record last verified: 2021-10