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

Inclusion Criteria Concurrent Medication: Allowed: Treatment for opportunistic infection that develops on study. Recommended: PCP prophylaxis if CD4 count falls below 200 cells/mm3. Patients must have: HIV infection. CD4 count 200 - 500 cells/mm3. HIV-1 RNA PCR value of 10000 copies/ml or higher. Asymptomatic or mildly symptomatic disease. No past or current AIDS-defining event. Consent of parent or guardian if less than legal age of consent. 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.