A Study of Multiple Doses of Vesnarinone in Advanced HIV Disease
This study has been completed.
Information provided by:
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1996
To evaluate the safety and tolerability of four doses of oral vesnarinone in patients with advanced HIV disease.
||Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
||A Phase I Safety and Tolerability Study of Four Doses of OPC-8212 (Vesnarinone) in Advanced HIV Disease
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
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).
- 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).
- Megestrol acetate.
- Agents known to cause neutropenia.
- Trimethoprim/sulfamethoxazole in excess of 160 mg trimethoprim and 800 mg sulfamethoxazole thrice weekly.
- Cytotoxic chemotherapy.
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.
- 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.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002337
|AIDS Research Consortium of Atlanta
|Atlanta, Georgia, United States, 30308 |
Otsuka America Pharmaceutical
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 2, 1999
||June 23, 2005
||United States: Food and Drug Administration
Keywords provided by NIH AIDS Clinical Trials Information Service:
Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Acquired Immunodeficiency Syndrome
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action