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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002154
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: March 1996

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002154 on ClinicalTrials.gov Archive Site
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A Study of Thioctic Acid and Deprenyl in HIV-Infected Patients With Dementia
Parallel Group, Placebo-Controlled, Tolerability and Safety Study of Thioctic Acid and Deprenyl in HIV Dementia

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).

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.

Interventional
Phase 2
Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
  • Cognitive Disorders
  • HIV Infections
  • Drug: Thioctic acid
  • Drug: Selegiline hydrochloride
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002154
250A, 03-D95
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The Dana Foundation
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NIH AIDS Clinical Trials Information Service
March 1996

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP