Safety and Tolerance of Zidovudine and Interferon-Alpha in HIV-Infected Children

Inclusion Criteria

Concurrent Medication:

Recommended:

• Prophylaxis for Pneumocystis carinii pneumonia.

Allowed:

• Aerosol ribavirin for short-term treatment of acute respiratory syncytial virus (RSV).
• Immunization according to the current recommendations of the Advisory Committee for Immunization Practice.
• IVIG. Systemic ketoconazole, acyclovir, or oral nystatin for acute therapy.

Patients must have the following:

• HIV infection. Patients with proven resistance to AZT are also eligible.

Prior Medication:

Allowed:

• Aerosol ribavirin.

Required:

Cohort C treatment:

• Stable prescribed dose of zidovudine (AZT) >= 90 mg/m2 for at least 6 weeks prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded: AIDS or class P-2B, D, or E symptomatic infection.

Concurrent Medication:

Excluded:

• Hepatotoxic or neurotoxic drugs, immunosuppressants, or antiseizure medication. Ketoconazole, fluconazole, and acyclovir for prophylaxis. Immunomodulators (other than IVIG). Experimental drugs.

Cohort A patients:

• AZT for clinical indications.

Prior Medication:

Excluded:

• Other antiretroviral agents (including didanosine (ddI), dideoxycytidine (ddC), or soluble CD4) within 1 month of study entry. Systemic ribavirin administered for retroviral therapy within 2 months of study entry.
• Immunomodulating agents including interferon, isoprinosine, interleukin-2, or lymphocyte transfusions within 4 weeks of study entry.
• RBC transfusion within 4 weeks prior to study entry.

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