Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000789
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Randomized Comparative Trial of Zidovudine AZT Versus 23-Didehydro-3-Deoxythymidine Stavudine d4T in Children With HIV Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Comparative Trial of Zidovudine AZT Versus 23-Didehydro-3-Deoxythymidine Stavudine d4T in Children With HIV Infection
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:
PRIMARY To compare the relative safety and tolerance of oral zidovudine AZT versus oral stavudine d4T in symptomatic HIV-infected children
SECONDARY To compare the clinical virologic and immunologic responses between the two treatment groups and to obtain pharmacokinetic data for both drugs
At present AZT is considered the drug of choice for initial treatment of most children with HIV infection although disease progression or drug intolerance is associated with its long-term use In preliminary studies in children d4T another HIV inhibitor has been well tolerated although an optimum dose has not been determined
SECONDARY To compare the clinical virologic and immunologic responses between the two treatment groups and to obtain pharmacokinetic data for both drugs
At present AZT is considered the drug of choice for initial treatment of most children with HIV infection although disease progression or drug intolerance is associated with its long-term use In preliminary studies in children d4T another HIV inhibitor has been well tolerated although an optimum dose has not been determined
Detailed Description:
At present AZT is considered the drug of choice for initial treatment of most children with HIV infection although disease progression or drug intolerance is associated with its long-term use In preliminary studies in children d4T another HIV inhibitor has been well tolerated although an optimum dose has not been determined
Patients are randomized to receive either oral AZT or oral d4T Treatment continues until the last patient enrolled has received 52 weeks of therapy or until the study is terminated
Patients are randomized to receive either oral AZT or oral d4T Treatment continues until the last patient enrolled has received 52 weeks of therapy or until the study is terminated
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 |
|---|---|---|---|
| 11217 | REGISTRY | DAIDS ES Registry Number | None |