A Study of Thioctic Acid and Deprenyl in HIV-Infected Patients With Dementia

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to see if it is safe and effective to give thioctic acid and deprenyl (selegiline hydrochloride), alone or in combination, to HIV-infected patients who have mild to moderate dementia (a decline in their mental abilities).

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

Details

• Lead Sponsor: The Dana Foundation
• Treatments: Selegiline; Thioctic Acid

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

• Antiretrovirals provided dose has been stable for at least 6 weeks prior to study entry.

Patients must have:

• HIV seropositivity.

• Mild to moderate cognitive impairment (problems with short term memory, concentration, and feeling slowed down).

• No active opportunistic CNS infection.

• Ability to give informed consent.

Prior Medication:

Allowed:

• Prior antiretrovirals provided dose has been stable for at least the past 6 weeks.

• Prior thioctic acid or deprenyl.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Severe premorbid psychiatric illness including schizophrenia and major depression that would interfere with study compliance.

• CNS neoplasms.

• Any other clinically significant condition or laboratory abnormality that would preclude participation on study.

• Current participation in other drug studies.

Concurrent Medication:

Excluded:

• Chemotherapy for malignancy.

Patients with the following prior conditions are excluded:

• History of chronic neurological disorders such as serious head injury, documented stroke, multiple sclerosis, uncontrolled epilepsy, Tourette's syndrome, and other neurodegenerative processes such as Huntington's disease.

• Prior participation in this study.

• History of adverse reaction/allergy to thioctic acid or deprenyl.

Prior Medication:

Excluded:

• Other investigational drugs within 30 days prior to study entry.