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Home > "A" Clinical Trials Conditions > A Study of Multiple Doses of Vesnarinone in Advanced HIV Disease  A Study of Multiple Doses of Vesnarinone in Advanced HIV Disease
A Study of Multiple Doses of Vesnarinone in Advanced HIV Disease
For Condition: HIV Infections
Status: Completed
Sponsor(s): Otsuka America Pharmaceutical ,
Synopsis: To evaluate the safety and tolerability of four doses of oral vesnarinone in patients with advanced HIV disease.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Open Label, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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).
Total Enrollment: 56
Location and Contact Information:
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
United States
Additional Information:
Study ID Numbers: 234B; 22-93-252
Study Start Date:
Record last reviewed: April 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002337
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3. Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC
4. A Pilot Study of Fluconazole Plus Flucytosine for the Treatment of AIDS Patients With Acute Cryptococcal Meningitis.
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A Study of Multiple Doses of Vesnarinone in Advanced HIV Disease
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