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Cognition DisordersPhase 2NCT00013585

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

A Phase 2 study testing Selegiline hydrochloride in people with Cognition Disorders and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cognition Disorders, HIV Infections
What is being tested?
Selegiline hydrochloride
How many people
127 participants
Where
15 sitesUnited States
Study dates
Start not givento Dec 2005
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • Johns Hopkins Adult AIDS CRS

    Baltimore, Maryland, 21287

  • Massachusetts General Hospital ACTG CRS

    Boston, Massachusetts, 02114

  • Unc Aids Crs

    Chapel Hill, North Carolina, 27514

  • Northwestern University CRS

    Chicago, Illinois, 60611

  • Cook County Hosp. CORE Ctr.

    Chicago, Illinois, 60612

  • Univ. of Hawaii at Manoa, Leahi Hosp.

    Honolulu, Hawaii, 96816

  • UCLA CARE Center CRS

    Los Angeles, California, 90095

  • Beth Israel Med. Ctr., ACTU

    New York, New York, 10003

  • Columbia Univ., HIV Prevention and Treatment Medical Ctr.

    New York, New York, 10032

  • Hosp. of the Univ. of Pennsylvania CRS

    Philadelphia, Pennsylvania, 19104

  • The Miriam Hosp. ACTG CRS

    Providence, Rhode Island, 02906

  • Univ. of Rochester ACTG CRS

    Rochester, New York, 14642

  • Ucsd, Avrc Crs

    San Diego, California, 92103

  • University of Washington AIDS CRS

    Seattle, Washington, 98104

  • Washington U CRS

    St Louis, Missouri

Other trials in United States

About this study

Official title: Phase II, Placebo-Controlled, Double-Blind Study of the Selegiline Transdermal System (STS) in the Treatment of HIV-Associated Cognitive Impairment

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.

Read the 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.

Being tested
Selegiline hydrochloride
Keywords
Cognitive Disorders, AIDS Dementia Complex, Selegiline, Administration, Cutaneous, Neuroprotective Agents
Medical subject headings
Cognition Disorders, HIV Infections, Cognitive Dysfunction, AIDS Dementia Complex

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Selegiline hydrochlorideDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 outcomes (9)

  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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2001 (estimated)
  2. Study completionDec 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
127 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00013585
Sponsor's protocol ID
A5090
Other IDs
10075, ACTG A5090, AACTG A5090
Status last verified
Oct 2021
First submitted
22 Mar 2001
Last updated
1 Nov 2021
Results posted
No

Publications

  • 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.

    PubMed 15569045

  • 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.

    PubMed 14697901

  • McArthur JC. HIV dementia: an evolving disease. J Neuroimmunol. 2004 Dec;157(1-2):3-10. doi: 10.1016/j.jneuroim.2004.08.042.

    PubMed 15579274

  • 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.

    PubMed 10636157

  • 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.

    PubMed 11171916

  • 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.

    PubMed 18042509

  • 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.

    PubMed 21181521

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Selegiline hydrochloride in people with Cognition Disorders and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in cognitive performance Week 24 from screening. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00013585, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.

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