The Safety and Effectiveness of HBY 097 Used With or Without AZT in HIV-Infected Patients Who Have Mild or No Symptoms

Exclusion Criteria

• •Co-existing Condition:
• •Patients with the following symptoms or conditions are excluded:
• •Endocrine, hepatic, renal, or gastrointestinal disease.
• •Cardiovascular conduction disease.
• •Concomitant medical illness that may complicate study conduct or interpretation of results.
• •Other factors that may interfere with patient compliance.
• •Concurrent Medication:
• •Excluded:
• •Antiretroviral agents other than study drugs.
• •Oral contraceptives.
• •Cytotoxic chemotherapy.
• •Immunomodulators.
• •Antiproliferative agents.
• •Corticosteroids.
• •Anabolic steroids.
• •Estrogens.
• •Quinoxaline derivatives.
• •Concurrent Treatment:
• •Excluded:
• •Radiation therapy.
• •Patients with the following prior conditions are excluded:
• •History of hypersensitivity to quinoxaline derivatives or intolerance to AZT.
• •History of cardiovascular conduction disease.
• •Prior participation in this study or any study using HBY 097.
• •Recent use of a drug that interferes with drug metabolism, absorption, distribution, or excretion.
• •History of thyroid disease.
• •Prior Medication:
• •Excluded at any time:
• •Prior non-nucleoside reverse transcriptase inhibitors.
• •Excluded within 30 days prior to study entry:
• •Any antiretroviral therapy.
• •Oral contraceptives.
• •Immunomodulating agents such as systemic corticosteroids, interleukins, or interferons.
• •Cytotoxic chemotherapeutic agents.
• •Other investigational drugs.
• •Excluded within 6 months prior to study entry:
• •Immunotherapeutic vaccine.
• •Prior Treatment:
• •Excluded within 30 days prior to study entry:
• •Radiation therapy.
• •An experimental device. Current ethanol or illicit drug abuse.