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Home > "A" Clinical Trials Conditions > 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
A Phase I Trial to Evaluate Didanosine (ddI) in HIV-Infected Pregnant Women
For Condition: HIV Infections,Pregnancy
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Bristol-Myers Squibb
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Pharmacokinetics Study
Minimum Age/Maximum Age: 13 Years/
Genders: Female
Protocol Entry 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.
Total Enrollment: 12
Location and Contact Information:
Overall Study Official:
LivingstonE, Study Chair,
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752
United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
United States
Univ of Miami (Pediatric)
Miami, Florida, 33161
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499
United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
United States
Univ Hosp
New Orleans, Louisiana, 70112
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
United States
Harlem Hosp Ctr
New York City, New York, 10037
United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , 009365067
Puerto Rico
Mount Sinai Med Ctr / Pediatrics
New York City, New York, 10029
United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Additional Information:
Study ID Numbers: ACTG 249;
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000839
Other Hiv Infections Studies:
1. A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 Immunoglobulin G (rCD4-IgG) in HIV-1 Seropositive Women During the Last Trimester of Pregnancy and Their Newborns
2. The Safety and Effectiveness of Zidovudine in HIV-Infected Pregnant Women and Their Infants
3. Ultrasound and motivational enhancement for prenatal smoking cessation
4. Study for Future Families
5. Maternal glucose measurement in pregnancy using a continuous ambulatory subcutaneous monitor
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Other HIV Infections Clinical Trials
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A Phase I Trial to Evaluate Didanosine (ddI) in HIV-Infected Pregnant Women
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