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

Completed · Phase 1

Conditions studied: HIV Infections, Pregnancy

In brief

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.

Key facts

Study ID

NCT00000839

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

12

Expected to finish

2001-06-01

Last updated by the study team

2021-10-29

Who can join

Age: 13 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS — Los Angeles, California, United States
• UCSD Maternal, Child, and Adolescent HIV CRS — San Diego, California, United States
• Univ. of Florida Jacksonville NICHD CRS — Jacksonville, Florida, United States
• Univ. of Miami Ped. Perinatal HIV/AIDS CRS — Miami, Florida, United States
• Rush Univ. Med. Ctr. ACTG CRS — Chicago, Illinois, United States
• Tulane Univ. Health Science Ctr., Tulane Univ. Hosp. & Clinic — New Orleans, Louisiana, United States
• Tulane/LSU Maternal/Child CRS — New Orleans, Louisiana, United States
• NJ Med. School CRS — Newark, New Jersey, United States
• Columbia IMPAACT CRS — New York, New York, United States
• Incarnation Children's Ctr. — New York, New York, United States
• DUMC Ped. CRS — Durham, North Carolina, United States
• San Juan City Hosp. PR NICHD CRS — San Juan, Puerto Rico
• Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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