A Phase I Study of Three Doses of OPC-8212 (Vesnarinone) in HIV-Infected Persons With CD4+ Cell Number > 300 Cells/mm3
Completed · Phase 1
Conditions studied: HIV Infections
In brief
To examine the safety and tolerance of three doses of oral vesnarinone in HIV-infected patients with CD4 count \> 300 cells/mm3.
Key facts
- Study ID
- NCT00002129
- Run by
- Otsuka America Pharmaceutical
- People needed
- 36
- 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, mycobacteria, and herpes simplex.
- Patients must have:
- Asymptomatic HIV infection.
- CD4 count > 300 cells/mm3.
- No prior AIDS-defining illness or current constitutional symptoms of HIV disease.
You may not qualify if…
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Current history of cardiac disease, including patients who exhibit long QT syndrome on EKG screening.
- Active malignancy other than cutaneous basal cell carcinoma or in situ carcinoma of the cervix.
- Concurrent Medication:
- Excluded:
- Antiretroviral agents, including ddI, ddC, and AZT.
- Immunosuppressive agents.
- Investigational HIV drugs/therapies including vaccines.
- Interferon.
- Steroids (other than topical).
- Hematopoietins.
- Megestrol acetate.
- Trimethoprim/sulfamethoxazole in excess of 160 mg trimethoprim and 800 mg sulfamethoxazole thrice weekly.
- Cytotoxic chemotherapy.
- Concurrent Treatment:
- Excluded:
- Radiation therapy.
- Patients with the following prior conditions are excluded:
- Prior history of cardiac disease.
- History of agranulocytosis or severe (grade 3) drug-induced neutropenia or documented abnormalities in granulocyte number or function.
- Prior Medication:
- Excluded:
- AZT, ddI, and ddC within 14 days prior to study entry.
- Prior cytotoxic chemotherapy.
Where it is running
- UCLA School of Medicine — Los Angeles, California, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.