Parallel Group, Placebo-Controlled, Tolerability, Safety, and Efficacy Study of OPC-14117 in HIV Dementia

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Treatments: OPC 14117

Criteria

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).