Pharmacokinetics, Safety, Tolerance, and Activity of Nevirapine (BI-RG-587) Alone and in Combination With AZT in Mildly to Moderately Symptomatic HIV-1 Infected Children

Inclusion Criteria Concurrent Medication: Allowed: IV gammaglobulin therapy. Medications for PCP prophylaxis (e.g., TMP / SMX, dapsone, aerosolized and IV pentamidine). Fluconazole. Patients must have: HIV infection. A positive Polymerase Chain Reaction (PCR) is not acceptable as the sole evidence of HIV infection. Three out of five children in each age and dose group must have a serum p24 antigen level of 70 pg/ml or greater and/or a plasma viral titer of 50 TCID/ml or greater prior to study entry. Ability to be followed by their original trial center for the duration of the trial. Consent of parent or guardian. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: Lymphocytic interstitial pneumonitis if steroid-dependent or requiring supplemental oxygen or with a pretreatment paO2 < 70 mm Hg. Opportunistic or serious bacterial infections within 28 days prior to entry. Demonstrated intolerance to zidovudine prior to administration of nevirapine (in patients enrolled in the combination therapy phase of the study). CDC classification of P-2D (secondary infectious diseases) and/or P-2E (secondary cancers). Pre-existing malignancies. Concurrent Medication: Excluded: Other approved or investigational antiretroviral agents. All other investigational agents (except fluconazole). Glucocorticoids and steroid hormones. Dicumarol, warfarin, and other anticoagulants. Digitoxin. Valproic acid. Tolbutamide. Doxycycline. Chloramphenicol. Isoniazid. Phenobarbital and other barbiturates. Hepatotoxic drugs. Patients with prior participation in this trial are excluded. Prior Medication: Excluded: More than 6 weeks of prior zidovudine (AZT) therapy or more than 6 weeks of any other antiretroviral therapy. Excluded within 7 days prior to study entry: AZT (in monotherapy groups only). Excluded within 4 weeks prior to study entry: Other approved or investigational antiretroviral agents. All other investigational agents. Glucocorticoids and steroid hormones. Dicumarol, warfarin, and other anticoagulants. Digitoxin. Valproic acid. Tolbutamide. Doxycycline. Chloramphenicol. Isoniazid. Phenobarbital and other barbiturates. Active alcohol or drug abuse to impair compliance with the protocol.