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

The Dana Foundation

Status and phase: Completed; Phase 2

Conditions: HIV Infections; Cognitive Disorders

Treatments: Drug: Thioctic acid; Drug: Selegiline hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT00002154

250A

03-D95

Details and patient eligibility

About

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).

Full description

Patients are randomized to receive thioctic acid alone, deprenyl alone, thioctic acid/deprenyl, or placebo alone for 10 weeks, after which all patients may receive active drug on an open-label basis. Patients must have seven clinic visits.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.