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

Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cognitive Disorders; HIV Infections

Intervention: Thioctic acid (Drug); Selegiline hydrochloride (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: The Dana Foundation


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).

Clinical Details

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

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

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

Johns Hopkins Hosp, Baltimore, Maryland 212876965, United States

Columbia Univ, New York, New York 10032, United States

Univ of Rochester Med Ctr, Rochester, New York 14642, United States

Additional Information

Last updated: June 23, 2005

Page last updated: August 23, 2015

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