Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002006
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Phase III Pilot Study of Simultaneously Administered Rhu GM-CSF CHO Cell and Azidothymidine AZT in Patients With Severe HIV Infection and Leukopenia Pharmacokinetics and Feasibility
Sponsor:
Sandoz
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase III Pilot Study of Simultaneously Administered Rhu GM-CSF CHO Cell and Azidothymidine AZT in Patients With Severe HIV Infection and Leukopenia Pharmacokinetics and Feasibility
Status:
COMPLETED
Status Verified Date:
1990-01
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 assess the safety and efficacy of subcutaneously administered sargramostim granulocyte-macrophage colony-stimulating factor GM-CSF in increasing and maintaining the neutrophil count in HIV-infected adults who have developed neutropenia as a result of receiving the antiretroviral agent zidovudine AZT To assess the safety and efficacy of subcutaneously administered GM-CSF in increasing and maintaining the neutrophil count in HIV-infected adults with pre-existing neutropenia who are at high risk of developing hematologic intolerance while receiving the antiretroviral agent AZT for the first time To assess the potential therapeutic benefit of concomitant GM-CSF and AZT on the natural history of HIV infection and associated infectious complications
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 |
|---|---|---|---|
| 07936 | None | None | None |