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A Phase I Study of Three Doses of OPC-8212 (Vesnarinone) in HIV-Infected Persons With CD4+ Cell Number > 300 Cells/mm3

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Vesnarinone
Sponsored by
Otsuka America Pharmaceutical
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring vesnarinone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCLA School of Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Otsuka America Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT00002129
Brief Title
A Phase I Study of Three Doses of OPC-8212 (Vesnarinone) in HIV-Infected Persons With CD4+ Cell Number > 300 Cells/mm3
Official Title
A Phase I Study of Three Doses of OPC-8212 (Vesnarinone) in HIV-Infected Persons With CD4+ Cell Number > 300 Cells/mm3
Study Type
Interventional

2. Study Status

Record Verification Date
April 1996
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Otsuka America Pharmaceutical

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
vesnarinone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)
Enrollment
36 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Vesnarinone

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
UCLA School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
900121973
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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)
Results Reference
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A Phase I Study of Three Doses of OPC-8212 (Vesnarinone) in HIV-Infected Persons With CD4+ Cell Number > 300 Cells/mm3

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