A Study of Thioctic Acid and Deprenyl in HIV-Infected Patients With Dementia
Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cognitive Disorders; HIV Infections
Intervention: Thioctic acid (Drug); Selegiline hydrochloride (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: The Dana Foundation
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).
Clinical Details
Official title: Parallel Group, Placebo-Controlled, Tolerability and Safety Study of Thioctic Acid and Deprenyl in HIV Dementia
Study design: Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Johns Hopkins Hosp, Baltimore, Maryland 212876965, United States
Columbia Univ, New York, New York 10032, United States
Univ of Rochester Med Ctr, Rochester, New York 14642, United States
Additional Information
Last updated: June 23, 2005
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