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

Inclusion Criteria

Concurrent Medication:

Allowed:

• Aerosolized pentamidine.
• IV AZT during labor.

Patients must have:

• HIV infection.
• CD4 count > 50 and < 350 cells/mm3.
• AZT intolerance or resistance.
• Gestational age at least 26 weeks but not more than 36 weeks.
• Consent of guardian if necessary. The father of the fetus must also provide consent if available after reasonable attempts have been made to contact him.

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.