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:
Accepts Healthy Volunteers:
Patients must have:
Prior OPC-14117 other than on the current study.
Antiretroviral therapy if stable for 6 weeks prior to study entry (12 weeks for stavudine).
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.
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.
Other investigational drugs within the past 30 days. Alcoholism within past 6 months (more than 2 drinks daily).