Parallel Group, Placebo-Controlled, Tolerability, Safety, and Efficacy Study of OPC-14117 in HIV Dementia
NCT ID: NCT00002148
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
DOUBLE
Interventions
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OPC 14117
Eligibility Criteria
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Inclusion Criteria
* HIV seropositivity.
* Cognitive impairment.
Prior Medication:
Allowed:
* Prior OPC-14117 other than on the current study.
* Antiretroviral therapy if stable for 6 weeks prior to study entry (12 weeks for stavudine).
Exclusion Criteria
Patients with the following symptoms or conditions are excluded:
* Current opportunistic CNS infection (i.e., toxoplasmosis or cryptococcal meningitis).
* Severe pre-morbid psychiatric illness including schizophrenia and major depression that would interfere with protocol compliance.
* CNS neoplasms.
* Any other clinically significant condition or laboratory abnormality that would interfere with ability to participate on study.
* Current participation in other drug studies.
Patients with the following prior conditions are excluded:
* Past history of opportunistic CNS infection (i.e., toxoplasmosis or cryptococcal meningitis).
* 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.
* History of adverse reaction / allergy to OPC-14117.
* Prior participation on this study.
Prior Medication:
Excluded:
* Other investigational drugs within the past 30 days. Alcoholism within past 6 months (more than 2 drinks daily).
18 Years
ALL
No
Sponsors
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University of Rochester
OTHER
Locations
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Johns Hopkins Hosp
Baltimore, Maryland, United States
Columbia Univ
New York, New York, United States
Univ of Rochester Med Ctr
Rochester, New York, United States
Countries
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References
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Safety and tolerability of the antioxidant OPC-14117 in HIV-associated cognitive impairment. The Dana Consortium on the Therapy of HIV Dementia and Related Cognitive Disorders. Neurology. 1997 Jul;49(1):142-6. doi: 10.1212/wnl.49.1.142.
Other Identifiers
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02-D94
Identifier Type: -
Identifier Source: secondary_id
242A
Identifier Type: -
Identifier Source: org_study_id