A Randomized Comparative Trial of Zidovudine (AZT) Versus 2',3'-Dideoxyinosine (ddI) Versus AZT Plus ddI in Symptomatic HIV-Infected Children

Inclusion Criteria Concurrent Medication: Allowed: Acetaminophen, ibuprofen, or aspirin, but not on a continual basis for > 72 hours. Systemic ketoconazole and fluconazole for acute therapy. Recommended: Prophylaxis for PCP. (Primary prophylaxis with TMP / SMX is encouraged.) IV pentamidine may be used in selected cases if not administered on a weekly basis. Patients must have the following: HIV infection. Children randomized prior to their eighteenth birthday are eligible. Co-enrollment in either ACTG 179 or 189 is permitted. Prior Medication: Allowed: Up to six weeks of antiretroviral or immunomodulator treatment excluding steroids and intravenous immunoglobulin. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Active malignancy. Pancreatitis or history of pancreatitis within one year prior to study entry associated with compatible symptoms. History of uncontrolled seizure disorder. Grade 3 or higher peripheral neuropathy. Cardiomyopathy. Concurrent Medication: Excluded: Chemotherapy for malignancy. Oral acidifying agents. Acetaminophen, ibuprofen, or aspirin on a continual basis for > 72 hours. Ketoconazole or fluconazole for prophylaxis. Drugs with potential to cause peripheral neuropathy or pancreatitis should not be given daily for > 4 weeks. Patients with the following are excluded: Active malignancy. Pancreatitis or history of pancreatitis within one year prior to study entry associated with compatible symptoms. History of uncontrolled seizure disorder. Grade 3 or higher peripheral neuropathy. Prior Medication: Excluded: Steroids. Intravenous immunoglobulin. Antiretroviral drugs or specific immunomodulator treatment (excluding steroids and intravenous immunoglobulin) for > 6 weeks and within 7 days prior to study entry. Prior Treatment: Excluded: Red blood cell transfusion within four weeks prior to study entry. Ongoing drug or alcohol use.