A Phase I Trial to Evaluate Didanosine (ddI) in HIV-Infected Pregnant Women
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of May 10, 2025
Completed
Keywords
ClinConnect Summary
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.
Patients receive a single IV dose of ddI on day 1 and pharmacokinetics values are determined. At least 48 hours but no more than 1 week after the IV dose, patients receive an oral dose, and oral pharmacokinetics are obtained for 8 hours. Oral ddI is then administered every 12 hours until labor commences and then after ...
Gender
FEMALE
Eligibility 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.
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
San Diego, California, United States
Chicago, Illinois, United States
New Orleans, Louisiana, United States
Newark, New Jersey, United States
Los Angeles, California, United States
Miami, Florida, United States
New York, New York, United States
Durham, North Carolina, United States
San Juan, , Puerto Rico
San Juan, , Puerto Rico
Jacksonville, Florida, United States
New York, New York, United States
New Orleans, Louisiana, United States
Patients applied
Trial Officials
Livingston E
Study Chair
Bartlett JA
Study Chair
Unadkat J
Study Chair
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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