A Phase I Study of Three Doses of OPC-8212 (Vesnarinone) in HIV-Infected Persons With CD4+ Cell Number > 300 Cells/mm3

Phase 1

Completed

• Conditions: HIV Infections

• Registration Number: NCT00002129
• Lead Sponsor: Otsuka America Pharmaceutical

Brief Summary

To examine the safety and tolerance of three doses of oral vesnarinone in HIV-infected patients with CD4 count \> 300 cells/mm3.

Detailed Description

Twelve patients per dose level receive vesnarinone at 1 of 3 doses for 12 weeks. At least six patients at a given dose level must have completed 2 weeks of treatment before dose is escalated in subsequent patients.

Study Timeline

• Status Verified: 1996-04
• 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: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

UCLA School of Medicine; 🇺🇸 Los Angeles, California, United States