Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000662
Status:
COMPLETED
Last Update Posted:
2016-10-31
First Post:
1999-11-02
Brief Title:
A Treatment IND for Retrovir Brand Zidovudine AZT Therapy of Pediatric Patients With HIV Disease
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Treatment IND for Retrovir Brand Zidovudine AZT Therapy of Pediatric Patients With HIV Disease
Status:
COMPLETED
Status Verified Date:
1992-04
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 facilitate the use of zidovudine AZT in children who are 3 months to 12 years of age who are HIV-infected and either symptomatic or have a CD4 cell count 400 cellsmm3 and to monitor adverse effects of AZT
Previous studies with pediatric patients have shown improvements in clinical immunologic and virologic parameters with administration of AZT
Previous studies with pediatric patients have shown improvements in clinical immunologic and virologic parameters with administration of AZT
Detailed Description:
Previous studies with pediatric patients have shown improvements in clinical immunologic and virologic parameters with administration of AZT
This Treatment IND investigational new drug is an open label uncontrolled protocol AZT is ordered and prescribed by the patients physician The physician is responsible for obtaining informed consent assuring that the patient meets the eligibility criteria dispensing the medication to the patient monitoring the patients condition on treatment and reporting required data to the project coordinating center
This Treatment IND investigational new drug is an open label uncontrolled protocol AZT is ordered and prescribed by the patients physician The physician is responsible for obtaining informed consent assuring that the patient meets the eligibility criteria dispensing the medication to the patient monitoring the patients condition on treatment and reporting required data to the project coordinating center
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 43A | None | None | None |