Parallel Group, Placebo-Controlled, Tolerability, Safety, and Efficacy Study of OPC-14117 in HIV Dementia
This study has been completed.
Sponsor:
University of Rochester
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002148
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: March 1996
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To assess the tolerability and safety of OPC-14117. To evaluate effects of OPC-14117 on cognitive function, quality of life, and activities of daily living.
Condition | Intervention | Phase |
---|---|---|
Cognitive Disorders HIV Infections |
Drug: OPC 14117 |
Phase 1 |
Study Type: | Interventional |
Study Design: | Endpoint Classification: Safety Study Masking: Double-Blind Primary Purpose: Treatment |
Official Title: | Parallel Group, Placebo-Controlled, Tolerability, Safety, and Efficacy Study of OPC-14117 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/20130307130310im_/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
Patients must have:
- 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
Co-existing Condition:
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).
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00002148
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
University of Rochester
![](https://webarchive.library.unt.edu/web/20130307130310im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Publications:
ClinicalTrials.gov Identifier: | NCT00002148 History of Changes |
Other Study ID Numbers: | 242A, 02-D94 |
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:
Cognition Disorders Acquired Immunodeficiency Syndrome AIDS-Related Complex |
Free Radical Scavengers Antioxidants OPC 14117 |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome AIDS Dementia Complex 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 Brain Diseases Central Nervous System Diseases Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on March 05, 2013