Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000855
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
1999-11-02
Brief Title:
A Study to Evaluate the Safety and Tolerability of Zidovudine ZDV in Premature Infants Born to HIV-Positive Women
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
The Safety Tolerance and Pharmacokinetics of Zidovudine in Premature Infants Exposed to HIV
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:
The purpose of this study is to examine the safety and tolerability of ZDV when given to premature infants born to HIV-positive women to prevent HIV infection
ZDV has been used successfully to prevent the transmission of HIV from mother to child during pregnancy and birth However ZDV has been given to very few premature babies and the best dose to use has not yet been determined
ZDV has been used successfully to prevent the transmission of HIV from mother to child during pregnancy and birth However ZDV has been given to very few premature babies and the best dose to use has not yet been determined
Detailed Description:
In the preliminary group of premature infants those receiving q 6h dosing had an average trough concentration of 73 uM 18 However the premature infants in the preliminary pharmacokinetic study did not have long term follow-up to assess toxicity Due to the potential for altered ZDV pharmacokinetics and increased toxicity in this population an evaluation of ZDV pharmacokinetics in premature infants is proposed
Premature infants less than or equal to 34 weeks gestational age at birth and begun on ZDV by their clinical caregivers will be entered into the protocol within the first 5 days of life Upon entry ZDV will be administered every 12 hours intravenously or orally The study will require 9 serum samples for ZDV assay collected over 30 days some additional clinical laboratory tests collected over 12 weeks collection of 3 spot urine samples and collection of routine clinical data
Premature infants less than or equal to 34 weeks gestational age at birth and begun on ZDV by their clinical caregivers will be entered into the protocol within the first 5 days of life Upon entry ZDV will be administered every 12 hours intravenously or orally The study will require 9 serum samples for ZDV assay collected over 30 days some additional clinical laboratory tests collected over 12 weeks collection of 3 spot urine samples and collection of routine clinical data
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 |
|---|---|---|---|
| 11303 | REGISTRY | DAIDS ES Registry Number | None |