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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002154
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

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).

Condition or disease Intervention/treatment Phase
Cognitive Disorders HIV Infections Drug: Thioctic acid Drug: Selegiline hydrochloride Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 32 participants
Masking: Double
Primary Purpose: Treatment
Official Title: Parallel Group, Placebo-Controlled, Tolerability and Safety Study of Thioctic Acid and Deprenyl in HIV Dementia

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 0 Years
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

Concurrent Medication:


  • 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:


  • 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:


  • 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:


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002154

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United States, Maryland
Johns Hopkins Hosp
Baltimore, Maryland, United States, 212876965
United States, New York
Columbia Univ
New York, New York, United States, 10032
Univ of Rochester Med Ctr
Rochester, New York, United States, 14642
Sponsors and Collaborators
The Dana Foundation
Layout table for additonal information Identifier: NCT00002154    
Other Study ID Numbers: 250A
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: March 1996
Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
Cognition Disorders
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Thioctic Acid
Additional relevant MeSH terms:
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Cognition Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Thioctic Acid
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex