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

Completed · Phase 2

Conditions studied: Cognition Disorders, HIV Infections

In brief

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.

Key facts

Study ID

NCT00013585

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

127

Expected to finish

2005-12-01

Last updated by the study team

2021-11-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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