A Study of Thioctic Acid and Deprenyl in HIV-Infected Patients With Dementia
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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. |
ClinicalTrials.gov Identifier: NCT00002154 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: June 24, 2005
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cognitive Disorders HIV Infections | Drug: Thioctic acid Drug: Selegiline hydrochloride | Phase 2 |
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 |

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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 ClinicalTrials.gov identifier (NCT number): NCT00002154
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 |
ClinicalTrials.gov Identifier: | NCT00002154 History of Changes |
Other Study ID Numbers: |
250A 03-D95 |
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 Selegiline |
Additional relevant MeSH terms:
HIV Infections Dementia Cognition Disorders Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurocognitive Disorders |
Mental Disorders Thioctic Acid Selegiline Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients Growth Substances Antiparkinson Agents Anti-Dyskinesia Agents Monoamine Oxidase Inhibitors Enzyme Inhibitors |