Cognitive Disorders, HIV Infections
Conditions
Keywords
Cognition Disorders, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Free Radical Scavengers, Antioxidants, OPC 14117
Brief summary
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.
Detailed description
Patients receive OPC-14117 or placebo bid for 12 weeks, followed by 12 weeks of open label therapy.
Interventions
DRUGOPC 14117
Sponsors
University of Rochester
Study design
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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).
Countries
United States
Outcome results
None listed