Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002126
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Randomized Controlled Multicenter Trial of Filgrastim Recombinant-Methionyl Human Granulocyte Colony Stimulating Factor G-CSF for the Prevention of Grade 4 Neutropenia in Patients With HIV Infection
Sponsor:
Amgen
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Randomized Controlled Multicenter Trial of Filgrastim Recombinant-Methionyl Human Granulocyte Colony Stimulating Factor G-CSF for the Prevention of Grade 4 Neutropenia in Patients With HIV Infection
Status:
COMPLETED
Status Verified Date:
1996-03
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 in HIV-infected patients the efficacy of filgrastim recombinant-methionyl human granulocyte-colony stimulating factor G-CSF in preventing grade 4 neutropenia ie absolute neutrophil count ANC 500 cellsmm3
Detailed Description:
Patients are randomized to receive subcutaneous G-CSF at one of two different doses or no G-CSF observation for 24 weeks Patients who experience ANC 500 cellsmm3 on two consecutive occasions at least 24 hours apart prior to completing the 24-week study period will be considered to have reached the primary study endpoint those in the observation group who reach the primary endpoint prior to week 24 may begin receiving G-CSF for the remainder of the study period After 24 weeks patients may continue G-CSF on a compassionate basis at the investigators discretion
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 |
|---|---|---|---|
| GCSF-930101 | None | None | None |