A Study of Dideoxycytidine Plus Zidovudine (AZT) in HIV-Infected Children Who Have Taken AZT

Inclusion Criteria

Concurrent Medication:

Recommended:

• PCP prophylaxis.

Allowed:

• Intravenous and/or intramuscular immunoglobulin.
• Acyclovir (no more than 30 mg/kg/day PO).
• Ketoconazole (no more than 10 mg/kg/day).
• Nystatin.
• Aspirin, acetaminophen, nonsteroidal anti-inflammatory drugs, sedatives, and barbiturates, not to exceed 72 hours.
• Isoniazid in combination with pyridoxine, provided there is no evidence of peripheral neuropathy.
• Trimethoprim / sulfamethoxazole.
• Amphotericin B (no more than 1 mg/kg for 5 days/week).
• Aerosolized ribavirin for bronchiolitis.
• Hematopoietic agents.
• Other drugs with little nephro-, hepato-, or cytotoxicity.
• Nutritional support for HIV wasting syndrome or malnutrition.

Patients must have:

• HIV infection.
• Ongoing stable AZT therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

• Disease progression while on AZT, to the extent that the patient meets the criteria for advanced disease protocols.
• Known allergy or sensitivity to ddC.
• Cardiomyopathy.

Concurrent Medication:

Excluded:

• Biologic modifiers other than IVIG, steroids, or hematopoietic agents.
• Investigational medications unless approved by protocol chair.
• Medications known to cause pancreatitis (unless ddC is interrupted while these medications are given).

Patients with the following prior conditions are excluded:

• History of intolerance or toxicity to AZT.
• History of symptomatic pancreatitis.
• History of peripheral neuropathy or abnormal nerve conduction velocity test.

Prior Medication:

Excluded:

• Antiretroviral agents other than AZT within 2 weeks of study entry.

Required:

• Ongoing stable AZT therapy for more than 6 weeks duration.