A Study of Thioctic Acid and Deprenyl in HIV-Infected Patients With Dementia
This study has been completed.
Sponsor:
The Dana Foundation
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
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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 2 |
Study Type: | Interventional |
Study Design: | Endpoint Classification: Safety Study Masking: Double-Blind Primary Purpose: Treatment |
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:
![](https://webarchive.library.unt.edu/web/20130307130316im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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.
![](https://webarchive.library.unt.edu/web/20130307130316im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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 | |
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
![](https://webarchive.library.unt.edu/web/20130307130316im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
ClinicalTrials.gov Identifier: | NCT00002154 History of Changes |
Other Study ID Numbers: | 250A, 03-D95 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
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 |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Cognition Disorders Dementia Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Thioctic Acid Selegiline Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients Growth Substances Monoamine Oxidase Inhibitors |
ClinicalTrials.gov processed this record on March 05, 2013