Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000701
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
A Phase I Evaluation of Azidothymidine AZT in Children With Acquired Immune Deficiency Syndrome AIDS or AIDS Related Complex ARC
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 Evaluation of Azidothymidine AZT in Children With Acquired Immune Deficiency Syndrome AIDS or AIDS Related Complex ARC
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 study is designed to test the drug zidovudine AZT in children including study of drug levels in various parts of the body fluids safety of the drug and its effect on different parts of the body
The effects of any drug the way a drug enters the bloodstream the way it is used by the body and the way the body eliminates the drug may be very different in children compared with adults The largest group of children who have AIDS are those who are less than 2 years of age AIDS is often first identified in infants who are about 6 months old Studies of AZT show that it might be useful in the treatment of AIDS Thus it is important to study the effects of the drug in children
The effects of any drug the way a drug enters the bloodstream the way it is used by the body and the way the body eliminates the drug may be very different in children compared with adults The largest group of children who have AIDS are those who are less than 2 years of age AIDS is often first identified in infants who are about 6 months old Studies of AZT show that it might be useful in the treatment of AIDS Thus it is important to study the effects of the drug in children
Detailed Description:
The effects of any drug the way a drug enters the bloodstream the way it is used by the body and the way the body eliminates the drug may be very different in children compared with adults The largest group of children who have AIDS are those who are less than 2 years of age AIDS is often first identified in infants who are about 6 months old Studies of AZT show that it might be useful in the treatment of AIDS Thus it is important to study the effects of the drug in children
Patients are hospitalized for 8 weeks to receive AZT through the intravenous IV route at 1 of 2 doses Patients are then discharged from hospital and take AZT by mouth for 4 more weeks
Patients are hospitalized for 8 weeks to receive AZT through the intravenous IV route at 1 of 2 doses Patients are then discharged from hospital and take AZT by mouth for 4 more weeks
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 |
|---|---|---|---|
| 10979 | REGISTRY | DAIDS ES Registry Number | None |
| Protocol 26541-004 | None | None | None |
| Project p53 | None | None | None |