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.
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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of vesnarinone in modulating HIV replication and immune response pathways?
How does vesnarinone compare to standard-of-care antiretroviral therapies in early-phase HIV trials?
Which biomarkers correlate with vesnarinone efficacy in HIV patients with CD4+ > 300 cells/mm3?
What adverse events are associated with vesnarinone in phase I HIV treatment studies?
Are there combination therapies involving vesnarinone and other HIV protease inhibitors under investigation?
Trial Locations
- Locations (1)
UCLA School of Medicine
🇺🇸Los Angeles, California, United States
UCLA School of Medicine🇺🇸Los Angeles, California, United States