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

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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.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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