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

Primary Purpose

HIV Infections, Pregnancy

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Didanosine
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Pregnancy Trimester, Third, Pregnancy, Pregnancy Complications, Infectious, Didanosine, Acquired Immunodeficiency Syndrome, AIDS-Related Complex

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
  • UCSD Maternal, Child, and Adolescent HIV CRS
  • Univ. of Florida Jacksonville NICHD CRS
  • Univ. of Miami Ped. Perinatal HIV/AIDS CRS
  • Rush Univ. Med. Ctr. ACTG CRS
  • Tulane Univ. Health Science Ctr., Tulane Univ. Hosp. & Clinic
  • Tulane/LSU Maternal/Child CRS
  • NJ Med. School CRS
  • Columbia IMPAACT CRS
  • Incarnation Children's Ctr.
  • DUMC Ped. CRS
  • San Juan City Hosp. PR NICHD CRS
  • Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00000839
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2001 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Bristol-Myers Squibb

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Pregnancy
Keywords
Pregnancy Trimester, Third, Pregnancy, Pregnancy Complications, Infectious, Didanosine, Acquired Immunodeficiency Syndrome, AIDS-Related Complex

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
12 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Didanosine

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Livingston E
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bartlett JA
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Unadkat J
Official's Role
Study Chair
Facility Information:
Facility Name
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UCSD Maternal, Child, and Adolescent HIV CRS
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Univ. of Florida Jacksonville NICHD CRS
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
City
Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Rush Univ. Med. Ctr. ACTG CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Tulane Univ. Health Science Ctr., Tulane Univ. Hosp. & Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Tulane/LSU Maternal/Child CRS
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
NJ Med. School CRS
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Columbia IMPAACT CRS
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Incarnation Children's Ctr.
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
DUMC Ped. CRS
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
San Juan City Hosp. PR NICHD CRS
City
San Juan
ZIP/Postal Code
00936
Country
Puerto Rico
Facility Name
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
City
San Juan
ZIP/Postal Code
00936
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
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)
Results Reference
background
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
Results Reference
background
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)
Results Reference
background

Learn more about this trial

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

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