A Phase I Trial to Evaluate Didanosine (ddI) in HIV-Infected Pregnant Women

Exclusion Criteria

• •Co-existing Condition:
• •Patients with the following symptoms or conditions are excluded:
• •Multiple gestation.
• •Current obstetrical complication, such as major anomalies, growth retardation, abnormal fluid level, fetal hydrops, or placental abruption (placenta previa is allowed).
• •No access to a participating ACTU.
• •Concurrent Medication:
• •Excluded:
• •Drugs that might aggravate pancreatitis, such as steroids, isoniazid, and parenteral pentamidine.
• •Antiretrovirals other than ddI (although IV AZT is allowed during labor).
• •Patients with the following prior conditions are excluded:
• •History of stillbirth, neonatal loss, or previous infant with anomaly (history of preeclampsia or preterm labor is permitted).
• •History of maternal medical complications including but not limited to malabsorption syndrome, pancreatitis, neurological complications including grade 2 or worse peripheral neuropathy, symptomatic cholelithiasis, or prior active CMV disease requiring ganciclovir or foscarnet.
• •History of poor medical compliance not related to access to medical care.
• •Prior Medication:
• •Excluded:
• •ddI within 24 hours prior to study entry.