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| Sponsor: | University of Rochester |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002148 |
Purpose
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 I |
| 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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Contacts and 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 | |
More Information
| 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 |
|
Cognition Disorders Acquired Immunodeficiency Syndrome AIDS-Related Complex |
Free Radical Scavengers Antioxidants OPC 14117 |
|
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 |