HIV Infections
Conditions
Keywords
Acquired Immunodeficiency Syndrome, Antiviral Agents, vesnarinone
Brief summary
To examine the continued safety and tolerability of four doses of vesnarinone in HIV-infected patients who have completed a short-term study (less than 12 months on continuous treatment) of the drug.
Detailed description
Patients who have completed a limited duration study (less than 12 months of continuous treatment) of vesnarinone on protocols FDA 234A or FDA 234B and who have no current signs or symptoms of AIDS-defining illnesses may roll over to this study and continue receiving their regimen of vesnarinone for 12 months beyond their original participation.
Interventions
DRUGVesnarinone
Sponsors
Otsuka America Pharmaceutical
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Concurrent Medication: Allowed: * Chemoprophylaxis for Pneumocystis carinii, candida, and mycobacteria. * Acyclovir for acute treatment of herpes.
Exclusion criteria
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). * Megestrol acetate. * Agents known to cause neutropenia. * Ganciclovir. * Cytotoxic chemotherapy. Concurrent Treatment: Excluded: * Radiation therapy. Patients with the following prior conditions are excluded: * Poor compliance (less than 80 percent of drug taken) on the Phase I protocol (FDA 234A or FDA 234B). * Missed more than one clinic visit on the Phase I protocol. Prior Medication: Excluded: * Acyclovir as prophylaxis for herpes within 48 hours prior to study entry. Patients meet the following criteria: Successful completion of short-term therapy with vesnarinone on FDA 234A or FDA 234B. Active illicit drug abuse.
Countries
United States
Outcome results
None listed