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

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS); Neurologic AIDS Research Consortium (NARC)
• Treatments: Selegiline

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