A Phase I Trial to Evaluate Didanosine (ddI) in HIV-Infected Pregnant Women
NCT ID: NCT00000839
Last Updated: 2021-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2001-06-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Didanosine
Eligibility Criteria
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Inclusion Criteria
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
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.
13 Years
FEMALE
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Livingston E
Role: STUDY_CHAIR
Bartlett JA
Role: STUDY_CHAIR
Unadkat J
Role: STUDY_CHAIR
Locations
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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
Countries
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References
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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)
Other Identifiers
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11226
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 249
Identifier Type: -
Identifier Source: org_study_id