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A Study of Thioctic Acid and Deprenyl in HIV-Infected Patients With Dementia
This study has been completed.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
Sponsored by: The Dana Foundation
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002154
  Purpose

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 Intervention Phase
Cognitive Disorders
HIV Infections
Drug: Thioctic acid
Drug: Selegiline hydrochloride
Phase II

Study Type: Interventional
Study Design: Treatment, Double-Blind, Safety Study
Official Title: Parallel Group, Placebo-Controlled, Tolerability and Safety Study of Thioctic Acid and Deprenyl in HIV Dementia

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 32
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002154

Locations
United States, Maryland
Johns Hopkins Hosp
Baltimore, Maryland, United States, 212876965
United States, New York
Univ of Rochester Med Ctr
Rochester, New York, United States, 14642
Columbia Univ
New York, New York, United States, 10032
Sponsors and Collaborators
The Dana Foundation
  More Information

No publications provided

Study ID Numbers: 250A, 03-D95
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002154     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
Cognition Disorders
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Thioctic Acid
Selegiline

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Antioxidants
Vitamin B Complex
AIDS Dementia Complex
Acquired Immunodeficiency Syndrome
Alpha-lipoic Acid
Trace Elements
AIDS-Related Complex
Neuroprotective Agents
Immunologic Deficiency Syndromes
Cognition Disorders
Virus Diseases
Selegiline
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
HIV Infections
Vitamins
Sexually Transmitted Diseases
Micronutrients
Dementia
Retroviridae Infections
Thioctic Acid
Delirium

Additional relevant MeSH terms:
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Antioxidants
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Antiparkinson Agents
Infection
Neuroprotective Agents
Mental Disorders
Therapeutic Uses
Vitamins
Monoamine Oxidase Inhibitors
Micronutrients
Retroviridae Infections
RNA Virus Infections
Vitamin B Complex
Immune System Diseases
Growth Substances
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Protective Agents
Immunologic Deficiency Syndromes
Cognition Disorders
Pharmacologic Actions
Virus Diseases
Selegiline
Delirium, Dementia, Amnestic, Cognitive Disorders
HIV Infections
Sexually Transmitted Diseases

ClinicalTrials.gov processed this record on July 02, 2009