Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001357
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Subcutaneously Administered Interleukin-2 Therapy in HIV-Infected Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Subcutaneously Administered Interleukin-2 Therapy in HIV-Infected Patients
Status:
COMPLETED
Status Verified Date:
2002-04
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:
This is a Phase I dose-escalating safety study aimed at identifying the maximum tolerated dose MTD for an outpatient regimen while exposing the minimum number of patients to a dose less than MTD The anticipated accrual will be approximately 15 patients and the study will take one year to complete Patients will receive Proleukin Registered Trademark subcutaneously at their assigned dose level once per day for 5 days approximately every eight weeks for a total of 6 months A cycle of therapy is defined as 5 days of Proleukin Registered Trademark plus antiviral therapy followed by 7 weeks of antiviral therapy alone If tolerated each patient will receive 3 cycles of therapy and following completion of three cycles will be eligible for extended treatment IL-2 injections will be delivered by study personnel on an outpatient basis for at least the first cycle of therapy
Detailed Description:
This is a Phase I dose-escalating safety study aimed at identifying the maximum tolerated dose MTD for an outpatient regimen while exposing the minimum number of patients to a dose less than MTD The anticipated accrual will be approximately 15 patients and the study will take one year to complete Patients will receive Proleukin Registered Trademark subcutaneously at their assigned dose level once per day for 5 days approximately every eight weeks for a total of 6 months A cycle of therapy is defined as 5 days of Proleukin Registered Trademark plus antiviral therapy followed by 7 weeks of antiviral therapy alone If tolerated each patient will receive 3 cycles of therapy and following completion of three cycles will be eligible for extended treatment IL-2 injections will be delivered by study personnel on an outpatient basis for at least the first cycle of therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 93-I-0205 | None | None | None |