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

Sponsor

Otsuka America Pharmaceutical (Industry)

Overall Status

Completed

CT.gov ID

NCT00002129

Collaborator

(none)

Enrollment

Location

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Vesnarinone	Phase 1

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 Design

Study Type:

Interventional

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 0 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA School of Medicine	Los Angeles	California	United States	900121973

Sponsors and Collaborators

Otsuka America Pharmaceutical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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)

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00002129

Other Study ID Numbers:

234A
22-93-251

First Posted:

Aug 31, 2001

Last Update Posted:

Jun 24, 2005

Last Verified:

Apr 1, 1996

Keywords provided by , ,

vesnarinone

Additional relevant MeSH terms:

HIV Infections

Vesnarinone

Study Results

No Results Posted as of Jun 24, 2005