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

HIV Infections Clinical Trial

Official title:

Parallel Group, Placebo-Controlled, Tolerability and Safety Study of Thioctic Acid and Deprenyl in HIV Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002154
• Other study ID #: 250A
• Secondary ID: 03-D95
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: March 1996
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Disorders
• HIV Infections

Intervention

Drug:
• Thioctic acid

• Selegiline hydrochloride

Locations

Country	Name	City	State
United States	Johns Hopkins Hosp	Baltimore	Maryland
United States	Columbia Univ	New York	New York
United States	Univ of Rochester Med Ctr	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
The Dana Foundation

Country where clinical trial is conducted

United States,