A 1592U89 Open-Label Protocol for Adult Patients With HIV-1 Infection.

Inclusion Criteria Concurrent Medication: Allowed: Erythropoietin, G-CSF and GM-CSF. Patients must have: CD4+ cell count < 100 cells/mm3. HIV-1 RNA > 30,000 copies/ml. Signed, informed consent from parent or legal guardian for patient under 18 years of age. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Renal failure requiring dialysis. Hepatic failure evident by grade 3/4 hyperbilirubinemia and AST 5 times the upper limit of normal. Documented hypersensitivity to 1592U89. Serious medical conditions, such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction, that would compromise the safety of the patient. Participation in or ability to participate in an enrolling study of 1592U89. Required: At least 2 nucleoside reverse transcriptase inhibitors (NRTI) and one protease inhibitor (or intolerance to one protease inhibitor and one NRTI due to trying at least 2 different regimens with at least one protease inhibitor). Alcohol or illicit drug use that may interfere with the patient's compliance.