Parallel Group, Placebo-Controlled, Tolerability, Safety, and Efficacy Study of OPC-14117 in HIV Dementia
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ClinicalTrials.gov Identifier: NCT00002148 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: June 24, 2005
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cognitive Disorders HIV Infections | Drug: OPC 14117 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 30 participants |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | Parallel Group, Placebo-Controlled, Tolerability, Safety, and Efficacy Study of OPC-14117 in HIV Dementia |

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002148
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 |
Publications:
ClinicalTrials.gov Identifier: | NCT00002148 History of Changes |
Other Study ID Numbers: |
242A 02-D94 |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | March 1996 |
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 Dementia Cognition Disorders AIDS Dementia Complex Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurocognitive Disorders Mental Disorders |