Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002009
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Phase III Study of Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia
Sponsor:
Sandoz
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase III Study of Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia
Status:
COMPLETED
Status Verified Date:
1988-06
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 the maximum tolerated dose MTD and toxicity of sargramostim recombinant granulocyte-macrophage colony-stimulating factor GM-CSF given by continuous intravenous infusion CIV in patients with leukopenia in association with AIDS virus infection In addition single dose and steady state pharmacokinetics will also be determined
Detailed Description:
None
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 |
|---|---|---|---|
| 101 | None | None | None |