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.

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety