Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000839
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
A Phase I Trial to Evaluate Didanosine ddI in HIV-Infected Pregnant Women
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase I Trial to Evaluate Didanosine ddI in HIV-Infected Pregnant Women
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 112497 Maternal IV pharmacokinetic studies will not be performed after ddI IV formulation has expired 113097 Maternal and cord samples will be required regardless of whether mother has received continuous IV ddI during labor
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 112497 Maternal IV pharmacokinetic studies will not be performed after ddI IV formulation has expired 113097 Maternal and cord samples will be required regardless of whether mother has received continuous IV ddI during labor
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11226 | REGISTRY | DAIDS ES Registry Number | None |