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

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ClinicalTrials.gov Identifier: NCT00013585
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : May 21, 2012
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
Neurologic AIDS Research Consortium (NARC)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cognition Disorders HIV Infections Drug: Selegiline hydrochloride Phase 2

Detailed Description:

Cognitive impairment is a common adverse effect of HIV infection that can progress to dementia. ARVs are the only current therapy, but treatment response is frequently unsatisfactory, short lived, or the agents are poorly tolerated in doses adequate for central nervous system (CNS) penetration. An adjunctive therapy that interferes with the cascade of events triggered by the virus is likely to play an important role. Oral selegiline is an approved and marketed drug for the symptomatic treatment of Parkinson's disease. Studies suggest that selegiline has a neuroprotective effect and that it may exert a "rescue effect" on dying and injured neurons. This study proposes to use transdermal selegiline, which may deliver a greater dose level than oral administration, in the treatment of HIV-associated cognitive impairment.

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Phase II, Placebo-Controlled, Double-Blind Study of the Selegiline Transdermal System (STS) in the Treatment of HIV-Associated Cognitive Impairment
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Change in cognitive performance Week 24 from screening
  2. frequencies of adverse experiences, abnormal results on laboratory tests, changes over time in laboratory tests and vital signs

Secondary Outcome Measures :
  1. Clinical global impression by the investigator comparing selegiline-treated arms with the placebo arm
  2. clinical global impression by the subject comparing selegiline-treated arms with the placebo arm
  3. cognitive domain-specific scores compared between selegiline-treated arms and the placebo arm
  4. neuropsychologic function tests (NPZ-8)
  5. fatigue scale (quality of life)
  6. markers of immune activation and oxidative stress/apoptosis
  7. comparison of selegiline and active metabolite steady-state concentrations at Weeks 4, 12, and 24 to cognitive performance
  8. comparison of selegiline and active metabolite steady-state concentrations at Weeks 4, 12, and 24 to historical data in normal volunteers after 7 days of transdermal selegiline administration
  9. comparison of selegiline and active metabolite steady-state concentrations at Week 4 in subjects on ritonavir-containing protease inhibitor (PI) antiviral regimens, subjects on other PI regimens, and subjects on non-PI-containing antiviral regimens

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Note: This trial closed to accrual on 12/15/04. Use of the lower-dose STS was discontinued on 05/31/05. Any patients joining the study after 05/31/05 assigned to the interventional arm or who are currently enrolled in Step 2 will receive the higher-dose STS.

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00013585


Locations
United States, California
UCLA CARE Center CRS
Los Angeles, California, United States, 90095
Ucsd, Avrc Crs
San Diego, California, United States, 92103
United States, Hawaii
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, United States, 96816
United States, Illinois
Northwestern University CRS
Chicago, Illinois, United States, 60611
Cook County Hosp. CORE Ctr.
Chicago, Illinois, United States, 60612
United States, Maryland
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, United States, 02114
United States, Missouri
Washington U CRS
St. Louis, Missouri, United States
United States, New York
Beth Israel Med. Ctr., ACTU
New York, New York, United States, 10003
Columbia Univ., HIV Prevention and Treatment Medical Ctr.
New York, New York, United States, 10032
Univ. of Rochester ACTG CRS
Rochester, New York, United States, 14642
United States, North Carolina
Unc Aids Crs
Chapel Hill, North Carolina, United States, 27514
United States, Pennsylvania
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
The Miriam Hosp. ACTG CRS
Providence, Rhode Island, United States, 02906
United States, Washington
University of Washington AIDS CRS
Seattle, Washington, United States, 98104
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Neurological Disorders and Stroke (NINDS)
Neurologic AIDS Research Consortium (NARC)
Investigators
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
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Other Publications:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00013585     History of Changes
Other Study ID Numbers: A5090
10075 ( Registry Identifier: DAIDS ES )
ACTG A5090
AACTG A5090
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: May 21, 2012
Last Verified: May 2012

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Cognitive Disorders
AIDS Dementia Complex
Selegiline
Administration, Cutaneous
Neuroprotective Agents

Additional relevant MeSH terms:
HIV Infections
Cognition Disorders
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Neurocognitive Disorders
 Mental Disorders
Selegiline
Antiparkinson Agents
Anti-Dyskinesia Agents
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs