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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002129

Enrollment

Registered

2001-08-31

Start date

Unknown

Completion date

Unknown

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

vesnarinone

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.

Interventions

DRUGVesnarinone

Study design

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026