A Study of Multiple Doses of Vesnarinone in Advanced HIV Disease

Study Overview
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Brief Summary
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To evaluate the safety and tolerability of four doses of oral vesnarinone in patients with advanced HIV disease.

Detailed Description
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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.

Official Title
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A Phase I Safety and Tolerability Study of Four Doses of OPC-8212 (Vesnarinone) in Advanced HIV Disease

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Vesnarinone


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Vesnarinone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vesnarinone, Acquired Immunodeficiency Syndrome, Antiviral Agents