The Safety and Effectiveness of 935U83 in HIV-Infected Patients

Exclusion Criteria

• •Co-existing Condition:
• •Patient with the following symptoms or conditions are excluded:
• •Current evidence of chronic hepatitis of any etiology.
• •Seropositivity for HBsAg or hepatitis C virus by second generation ELISA.
• •Concurrent Medication:
• •Excluded:
• •Cytotoxic chemotherapy.
• •Other antiretroviral drugs.
• •Immunomodulators.
• •Foscarnet.
• •GM-CSF or G-CSF.
• •Erythropoietin.
• •Concurrent Treatment:
• •Excluded:
• •Radiation therapy.
• •Patients with the following prior conditions are excluded:
• •History of chemical, viral, or alcohol-induced clinical hepatitis within the past 3 years.
• •Prior Medication:
• •Excluded within the past 6 months:
• •Any antiretroviral therapy.
• •HIV immunotherapeutic vaccine.
• •Excluded within the past 4 weeks:
• •Cytotoxic chemotherapy.
• •Immunomodulating agents such as systemic corticosteroids, IL-2, alpha interferon, beta interferon, or gamma interferon.
• •Prior Treatment:
• •Excluded within the past 4 weeks:
• •Radiation therapy. Current alcohol or illicit drug use that may interfere with study compliance.