Completed

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

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What is being tested

Didanosine

Drug
Who is being recruted

HIV Infections

+ Pregnancy
Over 13 Years
How is the trial designed

Treatment Study

Phase 1
Interventional

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: October 29, 2021
Sourced from a government-validated database.Claim as a partner

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. 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 delivery, every 12 hours until 6 weeks postpartum. During labor and delivery, patients receive a loading dose of ddI followed by continuous infusion. Pharmacokinetics are obtained during infusion and also at 6 weeks postpartum. AS PER AMENDMENT 11/24/97: Maternal IV pharmacokinetic studies will not be performed after ddI IV formulation has expired (11/30/97). Maternal and cord samples will be required regardless of whether mother has received continuous IV ddI during labor.

Official TitleA Phase I Trial to Evaluate Didanosine (ddI) in HIV-Infected Pregnant Women 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: October 29, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
12 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
Over 13 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV Infections
Pregnancy
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.



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 13 locations
Suspended
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRSLos Angeles, United StatesSee the location
Suspended
UCSD Maternal, Child, and Adolescent HIV CRSSan Diego, United States
Suspended
Univ. of Florida Jacksonville NICHD CRSJacksonville, United States
Suspended
Univ. of Miami Ped. Perinatal HIV/AIDS CRSMiami, United States

Completed13 Study Centers