Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001071
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Study of Stem Cells and Filgrastim
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Pilot Study of Stem Cell Mobilization and Harvesting From the Peripheral Blood Using Filgrastim
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:
To determine the safety of stem cell harvesting after administration of filgrastim G-CSF to mobilize bone marrow stem cells into the peripheral blood in patients at various stages of HIV-1 infection as well as in HIV-negative volunteers To determine the surface phenotypic and functional characteristics as well as the viral load in the stem cells obtained following this procedure
Detailed Description:
Patients and volunteers receive seven daily subcutaneous injections of G-CSF On days 5 and 6 of drug administration patients have peripheral blood mononuclear cells harvested by leukapheresis HIV-positive patients are stratified into three cohorts based on CD4 count and presence of symptoms If no increase in number of harvested stem cells and no grade 4 bone pain toxicity occur in two of the first three patients in a cohort then the last three patients in that cohort will receive a dose escalation Patients are followed for 24 weeks
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 |
|---|---|---|---|
| 11261 | REGISTRY | DAIDS ES Registry Number | None |