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

• Status: Completed
• Trial end date: 2001-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

To assess the pharmacokinetics, safety, and toxicity of intravenous and oral didanosine (ddI) administration in third trimester pregnant women who are HIV positive but are either intolerant or resistant to zidovudine (AZT). To collect data on infant toxicity following maternal treatment with ddI during the third trimester of pregnancy.

AZT may not be the optimal antiretroviral agent for all pregnant women requiring therapy for HIV infection. Although ddI has been approved for use in HIV-infected adults and older children, the safety and pharmacokinetics of ddI in pregnant women has not yet been determined.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Bristol-Myers Squibb
• Treatments: Didanosine

Criteria

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.