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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000839
First received: November 2, 1999
Last updated: March 28, 2012
Last verified: August 2004

November 2, 1999
March 28, 2012
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Complete list of historical versions of study NCT00000839 on ClinicalTrials.gov Archive Site
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A Phase I Trial to Evaluate Didanosine (ddI) in HIV-Infected Pregnant Women
A Phase I Trial to Evaluate Didanosine (ddI) in HIV-Infected Pregnant Women

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.

Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Primary Purpose: Treatment
  • HIV Infections
  • Pregnancy
Drug: Didanosine
Not Provided
  • 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)
  • 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
  • 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)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
June 2001
Not Provided

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.
Female
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00000839
ACTG 249, 11226
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Bristol-Myers Squibb
Study Chair: Livingston E
Study Chair: Bartlett JA
Study Chair: Unadkat J
National Institute of Allergy and Infectious Diseases (NIAID)
August 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP