A Study of ddI in Children With AIDS Who Have Not Had Success With Zidovudine

Inclusion criteria

Concurrent Medication:

Allowed:

• Concomitant medications for the treatment of complications of AIDS.
• CAUTION:
• Concomitant use of ddI with the following drugs must be done with extreme caution:
• Other nucleosides (e.g., ganciclovir).
• Drugs with toxicities similar to those observed with ddI (e.g., phenytoin).
• Drugs with significant pancreatic toxicities, including many drugs used for treatment of major opportunistic infections.
• Use of Sulfonamides or intravenous pentamidine for treatment of acute Pneumocystis carinii pneumonia (PCP) requires discontinuation of ddI for a week following treatment of PCP.
• Caution should also be exercised with patients having intractable diarrhea or patients following a low sodium diet.

Patients must have the following:

• Diagnosis of AIDS. Demonstrated either significant deterioration despite parenteral dosing with zidovudine (AZT) or significant intolerance to AZT.

Signed informed consent by parent or legal guardian. Evaluations every 7-14 days while taking ddI for the first 4 months. Monthly follow-up is required thereafter.

Exclusion criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

• Acute pancreatitis or any history of pancreatitis.
• Seizures or a history of seizure disorder.
• Grade I or greater peripheral neuropathy.
• Preexisting cardiomyopathy.

Concurrent Medication:

Excluded:

• Zidovudine (AZT).
• Chemotherapy with cytotoxic agents.
• AVOID:
• Those agents that may cause pancreatitis such as:
• Pentamidine.
• Sulfonamides.
• Antituberculosis drugs.
• Cimetidine.
• Ranitidine.
• Corticosteroids.
• NOTE the cautionary statement in Patient Inclusion Concurrent Medication.

Patients with the following are excluded:

• Acute pancreatitis or any history of pancreatitis.
• Seizures or a history of seizure disorder.
• Grade I or greater peripheral neuropathy.
• Preexisting cardiomyopathy.

Prior Medication:

Excluded within 15 days of study entry:

• Any anti-retroviral except zidovudine (AZT).

Required:

• Zidovudine (AZT).