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Jacksonville, Florida 32209

  • Pregnancy

Purpose:

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.


Study 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 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.


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 is Available At:


Original ID:

ACTG 249


NCT ID:

NCT00000839


Secondary ID:

11226


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Female


Minimum Age:

13 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute of Allergy and Infectious Diseases (NIAID)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Pharmacokinetics Study,


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

12


Enrollment Type:


Overall Contact Information

Official Name:Livingston E
Study Chair

Study Dates

Completion Date:June 2001
Completion Type:Actual
Verification Date:August 2004
Last Changed Date:March 28, 2012
First Received Date:November 2, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Didanosine

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute of Allergy and Infectious Diseases (NIAID)
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Bristol-Myers Squibb

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Livingston E, Patil S, Unadkat J, McKinney R, Abreu E, Bardequez A, O'Sullivan M. Placental transfer of didanosine (ddI) and initial evaluation of didanosine toxicity in HIV-1 infected pregnant women and their offspring. Conf Retroviruses Opportunistic Infect. 1998 Feb 1-5;5th:121 (abstract no 226)
Reference Type:Reference
Citation:McKinney RE Jr. Ongoing and future trials of antiretroviral therapy in the pediatric AIDS clinical trials group (PACTG). Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:173
Reference Type:Reference
Citation:Patil SD, Livingston E, McKinney RE, Abreu E, O'Sullivan MJ, Bardequez A, Unadkat JD. Does pregnancy affect the pharmacokinetics of didanosine (ddI) in HIV-1 infected women? Conf Retroviruses Opportunistic Infect. 1998 Feb 1-5;5th:121 (abstract no 225)

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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