Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002197
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Study of 1592U89 in HIV-Infected Children
Sponsor:
Glaxo Wellcome
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
1592U89 Open-Label Protocol for Pediatric Patients With HIV Infection
Status:
COMPLETED
Status Verified Date:
1998-12
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 see if it is safe to give 1592U89 to children aged 6 months until 14th birthday with advanced HIV infection who have few treatment options available The study also examines the effect 1592U89 has on the levels of HIV in the blood
Detailed Description:
This is an open-label non-randomized study All patients will be treated with 1592U89 Additionally since optimal therapy usually includes the combined use of 2 or more antiretroviral agents in advanced patients other novel antiretroviral therapies may be accessed through commercial means or via compassionate use programs NOTE 1592U89 should not be administered as a single new agent added to a failing treatment regimen
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 |
|---|---|---|---|
| CNAA3007 | None | None | None |