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

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

Sponsors

Lead sponsor: Otsuka America Pharmaceutical

Source NIH AIDS Clinical Trials Information Service
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.

Overall Status Completed
Phase Phase 1
Study Type Interventional
Enrollment 36
Condition
Intervention

Intervention type: Drug

Intervention name: Vesnarinone

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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Location
facility UCLA School of Medicine
Location Countries

United States

Verification Date

April 1996

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov