Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001007
Status:
COMPLETED
Last Update Posted:
2008-07-15
First Post:
1999-11-02
Brief Title:
A Study of Zidovudine in Infants Exposed to the HIV Before or Soon After Birth
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Multicenter Phase I Trial To Evaluate the Safety and Pharmacokinetics of Intravenous and Oral Zidovudine in Infants With Perinatal Human Immunodeficiency Virus HIV Exposure
Status:
COMPLETED
Status Verified Date:
2003-01
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 determine if intravenous IV and oral zidovudine AZT can be safely given to children aged 1 day to 3 months who were born to mothers with an HIV infection Also to determine the correct dose of AZT for young children Of a total of 908 pediatric AIDS cases 78 percent have acquired HIV infection from a mother with HIV infection or at high risk for acquisition of HIV and the number of cases in children is expected to increase over the next several years AZT therapy may be effective in altering the course of the disease and decreasing the high mortality in these children It is also possible that early intervention with AZT may prevent the establishment of HIV contracted before during or just after birth
Detailed Description:
Of a total of 908 pediatric AIDS cases 78 percent have acquired HIV infection from a mother with HIV infection or at high risk for acquisition of HIV and the number of cases in children is expected to increase over the next several years AZT therapy may be effective in altering the course of the disease and decreasing the high mortality in these children It is also possible that early intervention with AZT may prevent the establishment of HIV contracted before during or just after birth
The children entered in this study receive oral and IV AZT The first 6 children receive 2 IV doses and 2 oral doses over a 2-week period then 4 weeks of continuous oral dosing 4 doses per day The remaining 12 children receive
1 IV dose and 1 oral dose followed by 6 weeks of oral AZT 4 doses per day and a second IV dose at the end of the study Each child is under the care of a specialist in pediatrics and has a physical examination and laboratory tests before starting AZT and 6 times while taking AZT to make sure the drug is not having a toxic effect on the child A single cerebrospinal fluid CSF sample is taken from the last 12 children entering the study so that the level of the AZT reaching the brain can be measured The child returns to the hospital or clinic 4 weeks after the end of therapy to make sure that there are no delayed toxic effects
The children entered in this study receive oral and IV AZT The first 6 children receive 2 IV doses and 2 oral doses over a 2-week period then 4 weeks of continuous oral dosing 4 doses per day The remaining 12 children receive
1 IV dose and 1 oral dose followed by 6 weeks of oral AZT 4 doses per day and a second IV dose at the end of the study Each child is under the care of a specialist in pediatrics and has a physical examination and laboratory tests before starting AZT and 6 times while taking AZT to make sure the drug is not having a toxic effect on the child A single cerebrospinal fluid CSF sample is taken from the last 12 children entering the study so that the level of the AZT reaching the brain can be measured The child returns to the hospital or clinic 4 weeks after the end of therapy to make sure that there are no delayed toxic effects
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 |
|---|---|---|---|
| FDA 9D | None | None | None |