A Long-Term, Follow-On Safety Study of Four Doses of OPC-8212 (Vesnarinone) in HIV-Infected Persons
Completed · Not applicable
Conditions studied: HIV Infections
In brief
To examine the continued safety and tolerability of four doses of vesnarinone in HIV-infected patients who have completed a short-term study (less than 12 months on continuous treatment) of the drug.
Key facts
- Study ID
- NCT00002130
- Run by
- Otsuka America Pharmaceutical
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Concurrent Medication:
- Allowed:
- Chemoprophylaxis for Pneumocystis carinii, candida, and mycobacteria.
- Acyclovir for acute treatment of herpes.
You may not qualify if…
- Concurrent Medication:
- Excluded:
- Antiretroviral agents, including ddI, ddC, AZT, and d4T.
- Immunosuppressive agents.
- Investigational HIV drugs/therapies including vaccines.
- Interferon or other immunomodulating agents.
- Corticosteroids (other than topical).
- Megestrol acetate.
- Agents known to cause neutropenia.
- Ganciclovir.
- Cytotoxic chemotherapy.
- Concurrent Treatment:
- Excluded:
- Radiation therapy.
- Patients with the following prior conditions are excluded:
- Poor compliance (less than 80 percent of drug taken) on the Phase I protocol (FDA 234A or FDA 234B).
- Missed more than one clinic visit on the Phase I protocol.
- Prior Medication:
- Excluded:
- Acyclovir as prophylaxis for herpes within 48 hours prior to study entry.
- Patients meet the following criteria:
- Successful completion of short-term therapy with vesnarinone on FDA 234A or FDA 234B.
- Active illicit drug abuse.
Where it is running
- UCLA School of Medicine — Los Angeles, California, United States
- AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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