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

Launched by BRISTOL-MYERS SQUIBB · Aug 30, 2001

Keywords

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Gender

ALL

Eligibility criteria

• • 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).

Trial Officials