- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002129
A Phase I Study of Three Doses of OPC-8212 (Vesnarinone) in HIV-Infected Persons With CD4+ Cell Number > 300 Cells/mm3
June 23, 2005 updated by: Otsuka America Pharmaceutical
To examine the safety and tolerance of three doses of oral vesnarinone in HIV-infected patients with CD4 count > 300 cells/mm3.
Study Overview
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 Type
Interventional
Enrollment
36
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States, 900121973
- UCLA School of Medicine
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria
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.
Exclusion Criteria
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.
Prior Treatment:
Excluded:
- Radiation therapy (including electron beam irradiation) within 30 days prior to study entry.
Active illicit drug abuse.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
August 30, 2001
First Posted (Estimate)
August 31, 2001
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
April 1, 1996
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Immunologic Factors
- Protective Agents
- Cardiotonic Agents
- Adjuvants, Immunologic
- Phosphodiesterase Inhibitors
- Vesnarinone
Other Study ID Numbers
- 234A
- 22-93-251
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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