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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To examine the safety and tolerance of three doses of oral vesnarinone in HIV-infected patients with CD4 count > 300 cells/mm3.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka America Pharmaceutical
• Treatments: Vesnarinone

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.