A Pilot Pharmacokinetic Phase I Evaluation of BI-RG-587 in HIV-Infected Children

Inclusion Criteria Concurrent Medication: Allowed: Intravenous gammaglobulin. Pneumocystis prophylaxis according to published guidelines. Patients must have the following: HIV infection. Parent or guardian must be available to give written informed consent. Exclusion Criteria Concurrent Medication: Excluded: Zidovudine (AZT). Steroid dependency. Excluded within 1 hour before and 4 hours after study drug administration: Drugs that might interfere with the absorption of study drug (H2 blockers, antacids, carafate, cholestyramine). Benzodiazepines. Alcohol-containing substances. Concurrent Treatment: Excluded: Requiring supplemental oxygen. Patients with the following are excluded: Active opportunistic or serious bacterial infection. Lymphoid interstitial pneumonitis (LIP) and steroid dependent or requiring supplemental oxygen or have a pretreatment pa02 < 70 mm Hg. Pre-existing malignancies. Prior Medication: Excluded: Zidovudine (AZT) within 7 days prior to administration of study drug. Excluded for at least 4 weeks prior to drug administration: Other approved or investigational antiretroviral agents. All other investigational agents. Biologic response modifiers (e.g., interferon) or immunomodulators. Immunosuppressive agents (including glucocorticoids). Coumadin and other anticoagulant medications. Prior Treatment: Excluded: Red blood cell transfusion within 4 weeks of study entry. Patients may not have the following: Opportunistic or serious bacterial infection. Zidovudine (AZT) > 7 days prior to administration of study drug. Active alcohol or drug abuse.