Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002255
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
An Open-Label Phase III Study of Recombinant Granulocyte Colony Stimulating Factor r-metHuG-CSF and Recombinant Erythropoietin rHuEPO Given Subcutaneously Along With Zidovudine AZT to Patients With the Acquired Immune Deficiency Syndrome AIDS or Severe AIDS-Related Complex ARC
Sponsor:
Amgen
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
An Open-Label Phase III Study of Recombinant Granulocyte Colony Stimulating Factor r-metHuG-CSF and Recombinant Erythropoietin rHuEPO Given Subcutaneously Along With Zidovudine AZT to Patients With the Acquired Immune Deficiency Syndrome AIDS or Severe AIDS-Related Complex ARC
Status:
COMPLETED
Status Verified Date:
1991-01
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 evaluate the safety tolerance and biological activity of filgrastim recombinant granulocyte colony stimulating factor G-CSF given by daily subcutaneous injection prior to and concomitantly with erythropoietin EPO and zidovudine AZT in patients with AIDS or severe ARC To evaluate the safety tolerance and biological activity of recombinant EPO given three times weekly by subcutaneous injection concomitantly with G-CSF and prior to and concomitantly with AZT in patients with AIDS or severe ARC To study the safety and tolerance of three dose levels of AZT given concomitantly with G-CSF and EPO in patients with AIDS or severe ARC To study the effects of G-CSF on neutrophil function and number in patients with AIDS or severe ARC To study the effect of G-CSF alone and in combination with EPO on HIV replication in vivo as measured by circulating HIV p24 antigen plasma HIV viremia and semiquantitative HIV cocultures
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 |
|---|---|---|---|
| G-CSF 8808 | None | None | None |