A Phase I Safety and Pharmacokinetics Study of 2',3'-Dideoxyinosine (ddI) Administered Twice Daily to Infants and Children With AIDS or Symptomatic HIV Infection

Exclusion Criteria

• •Co-existing Condition:
• •Children with the following are excluded:
• •Chronic hematologic disorders unrelated to coagulation defects, hemoglobinopathies, or ITP.
• •Intractable diarrhea.
• •No venous access.
• •History of seizures within previous 2 years or currently requiring anticonvulsants for control.
• •Currently active heart disease as evidenced by a cardiac arrhythmia or other significant abnormality on routine electrocardiography (ECG) or shortening fraction of \< 10 percent on echocardiogram.
• •Renal disease.
• •Any other clinical condition that in the opinion of the investigator makes the patient unsuitable for study.
• •Concurrent Medication:
• •Excluded:
• •Antiretroviral drugs.
• •Zidovudine (AZT).
• •AL 721.
• •Interferon.
• •Corticosteroids.
• •Immunomodulating drugs.
• •Other systemic investigation agent.
• •Ribavirin.
• •Rifampin, barbiturates, or any other potent inducer or inhibitor of drug-metabolizing enzymes.
• •Cytotoxic anticancer therapy.
• •H-2 blockers.
• •Intravenous ketoconazole.
• •Immunoglobulin preparations.
• •Children with the following are excluded:
• •Chronic hematologic disorders unrelated to coagulation defects, hemoglobinopathies, or ITP.
• •Intractable diarrhea.
• •No venous access.
• •History of seizures within previous 2 years or currently requiring anticonvulsants for control.
• •Currently active heart disease as evidenced by a cardiac arrhythmia or other significant abnormality on routine electrocardiography (ECG) or shortening fraction of \< 10 percent on echocardiogram.
• •Renal disease.
• •Any other clinical condition that in the opinion of the investigator makes the patient unsuitable for study.
• •Renal disease.
• •Prior Medication:
• •Excluded:
• •Any prior therapy which in the opinion of the investigator would make the patient unsuitable for study.
• •Excluded within 2 weeks of study entry:
• •Trimethoprim / sulfamethoxazole.
• •Excluded within 1 month of study entry:
• •Study drug or other antiretroviral drug or systemic investigational agent.
• •Any agent known as a potent inducer or inhibitor of drug metabolizing enzymes.
• •H-2 blockers.
• •Ketoconazole.
• •Immunoglobulin preparations.
• •Excluded within 3 months of study entry:
• •Ribavirin.
• •Excluded:
• •Zidovudine (AZT) for \> 6 months.
• •Cytotoxic anticancer therapy.
• •Prior Treatment:
• •Excluded within 4 weeks of study entry:
• •Blood transfusion.
• •Lymphocyte transfusions for immune reconstitution.
• •Bone marrow transplant.