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

Phase 1

Completed

• Conditions: Cognitive Disorders; HIV Infections

• Registration Number: NCT00002148
• Lead Sponsor: University of Rochester

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.

Study Timeline

• Status Verified: 1996-03
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (3)

Johns Hopkins Hosp; 🇺🇸 Baltimore, Maryland, United States

Columbia Univ; 🇺🇸 New York, New York, United States

Univ of Rochester Med Ctr; 🇺🇸 Rochester, New York, United States