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

Primary Purpose

Cognitive Disorders, HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Thioctic acid
Selegiline hydrochloride
Sponsored by
The Dana Foundation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Disorders focused on measuring Drug Therapy, Combination, Cognition Disorders, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Thioctic Acid, Selegiline

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Johns Hopkins Hosp
  • Columbia Univ
  • Univ of Rochester Med Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
The Dana Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00002154
Brief Title
A Study of Thioctic Acid and Deprenyl in HIV-Infected Patients With Dementia
Official Title
Parallel Group, Placebo-Controlled, Tolerability and Safety Study of Thioctic Acid and Deprenyl in HIV Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
March 1996
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
The Dana Foundation

4. Oversight

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Disorders, HIV Infections
Keywords
Drug Therapy, Combination, Cognition Disorders, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Thioctic Acid, Selegiline

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Enrollment
32 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Thioctic acid
Intervention Type
Drug
Intervention Name(s)
Selegiline hydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Johns Hopkins Hosp
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
212876965
Country
United States
Facility Name
Columbia Univ
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Univ of Rochester Med Ctr
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

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

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