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
2 other identifiers
interventional
32
1 country
3
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
March 1, 1996
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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:
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1996-03