Search / Trial NCT00002337

A Study of Multiple Doses of Vesnarinone in Advanced HIV Disease

Launched by OTSUKA AMERICA PHARMACEUTICAL · Aug 30, 2001

Trial Information

Current as of November 03, 2024

Completed

Keywords

Acquired Immunodeficiency Syndrome Antiviral Agents Vesnarinone

ClinConnect Summary

Fourteen patients per dose level receive vesnarinone at 1 of 4 doses for 12 weeks. At least seven patients at a given dose level must have completed 4 weeks of treatment before dose is escalated in subsequent patients.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Chemoprophylaxis for Pneumocystis carinii, candida, mycobacteria, and other opportunistic infections.
  • Acyclovir for up to 14 days for acute herpes outbreaks.
  • Patients must have:
  • Documented HIV infection.
  • CD4 count 50 - 300 cells/mm3.
  • No active opportunistic infections.
  • No fever, diarrhea, or Herpes zoster.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Clinically significant current cardiac disease, including patients who exhibit long QTC syndrome on EKG screening and who have an abnormal cardiothoracic ratio on chest x-ray at baseline.
  • Active malignancy (other than cutaneous Kaposi's sarcoma or cutaneous basal cell carcinoma or in situ carcinoma of the cervix).
  • Concurrent Medication:
  • Excluded:
  • Antiretroviral agents, including ddI, ddC, AZT, and d4T.
  • Immunosuppressive agents.
  • Investigational HIV drugs/therapies including vaccines.
  • Interferon or other immunomodulating agents.
  • Corticosteroids (other than topical).
  • Hematopoietins.
  • Megestrol acetate.
  • Agents known to cause neutropenia.
  • 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 or worse) drug-induced neutropenia or documented abnormalities in granulocyte function.
  • Prior Medication:
  • Excluded:
  • AZT, ddI, ddC, d4T, or other nucleoside analog antiretroviral therapy within 14 days prior to study entry.
  • Prior cytotoxic chemotherapy.
  • Acyclovir for herpes prophylaxis within 48 hours prior to study entry.
  • Prior Treatment:
  • Excluded within 30 days prior to study entry:
  • Erythropoietin, transfusion, or blood product use.
  • Radiation therapy (including electron beam irradiation). Active use of illicit drugs (specifically cocaine, amyl nitrate, heroin, and other cardioactive agents).

About Otsuka America Pharmaceutical

Otsuka America Pharmaceutical, Inc. is a leading biopharmaceutical company committed to improving the health and quality of life for patients through innovative research and development. A subsidiary of Otsuka Pharmaceutical Co., Ltd., based in Japan, Otsuka America focuses on delivering novel therapeutic solutions in areas such as mental health, nephrology, and oncology. With a strong emphasis on scientific integrity and collaboration, the company engages in clinical trials to advance its pipeline of drug candidates, striving to address unmet medical needs and enhance patient outcomes. Otsuka America is dedicated to ethical practices and upholding the highest standards in clinical research.

Locations

Atlanta, Georgia, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

Similar Trials