A Phase I Study of Three Doses of OPC-8212 (Vesnarinone) in HIV-Infected Persons With CD4+ Cell Number > 300 Cells/mm3
This study has been completed.
Information provided by:
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1996
To examine the safety and tolerance of three doses of oral vesnarinone in HIV-infected patients with CD4 count > 300 cells/mm3.
||Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
||A Phase I Study of Three Doses of OPC-8212 (Vesnarinone) in HIV-Infected Persons With CD4+ Cell Number > 300 Cells/mm3
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
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.
- Antiretroviral agents, including ddI, ddC, and AZT.
- Immunosuppressive agents.
- Investigational HIV drugs/therapies including vaccines.
- Steroids (other than topical).
- Megestrol acetate.
- Trimethoprim/sulfamethoxazole in excess of 160 mg trimethoprim and 800 mg sulfamethoxazole thrice weekly.
- Cytotoxic chemotherapy.
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.
- AZT, ddI, and ddC within 14 days prior to study entry.
- Prior cytotoxic chemotherapy.
- Radiation therapy (including electron beam irradiation) within 30 days prior to study entry.
Active illicit drug abuse.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002129
|UCLA School of Medicine
|Los Angeles, California, United States, 900121973 |
Otsuka America Pharmaceutical
Mitsuyasu R, Bort L, Miles SA, Hardy WD, Petit RG. Preliminary results of a phase I study of vesnarinone (OPC-8212) in HIV-infected persons with CD4 > 300 cells/MM3. Int Conf AIDS. 1994 Aug 7-12;10(1):8 (abstract no 005B)
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 2, 1999
||June 23, 2005
||United States: Food and Drug Administration
Keywords provided by NIH AIDS Clinical Trials Information Service:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 15, 2014
Acquired Immunodeficiency Syndrome
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action