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

Otsuka

Status and phase: Completed; Phase 1

Conditions: HIV Infections

Treatments: Drug: Vesnarinone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002129

22-93-251

234A

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.