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

NCT ID: NCT00002154

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL

Brief 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).

Detailed 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.

Conditions

Cognitive Disorders; HIV Infections

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Thioctic acid

Intervention Type: DRUG

Selegiline hydrochloride

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Dana Foundation

OTHER

Sponsor Role: lead

Locations

Johns Hopkins Hosp

Baltimore, Maryland, United States

Columbia Univ

New York, New York, United States

Univ of Rochester Med Ctr

Rochester, New York, United States

Countries

United States

Other Identifiers

03-D95

Identifier Type: -

Identifier Source: secondary_id

250A

Identifier Type: -

Identifier Source: org_study_id