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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: | Treatment, Double-Blind, Safety Study |
| 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 | |
| Univ of Rochester Med Ctr | |
| Rochester, New York, United States, 14642 | |
| Columbia Univ | |
| New York, New York, United States, 10032 | |
More Information
| Study ID Numbers: | 242A, 02-D94 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002148 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Cognition Disorders Acquired Immunodeficiency Syndrome AIDS-Related Complex |
Free Radical Scavengers Antioxidants OPC 14117 |
|
RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases AIDS Dementia Complex Disease Immune System Diseases Nervous System Diseases Acquired Immunodeficiency Syndrome Central Nervous System Diseases Brain Diseases Infection |
Cognition Disorders Immunologic Deficiency Syndromes Virus Diseases Pathologic Processes Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders HIV Infections Sexually Transmitted Diseases Lentivirus Infections Dementia Retroviridae Infections |