Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000821
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
Subcutaneously Administered Aldesleukin Interleukin-2 IL-2 Therapy in HIV-Infected Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Subcutaneously Administered Aldesleukin Interleukin-2 IL-2 Therapy in HIV-Infected Patients
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 compare the effects of low-dose versus high-dose subcutaneous SC aldesleukin interleukin-2 IL-2 on immunologic and virologic markers in HIV-infected patients To compare the effects of monthly versus bimonthly administration of SC IL-2 on these markers
Interleukin-2 is a protein that is naturally produced by lymphocytes In an initial study patients in an earlier stage of HIV-1 infection tended to tolerate SC IL-2 better than those with more advanced infections and those with higher baseline CD4 counts tended to derive the greatest benefit
Interleukin-2 is a protein that is naturally produced by lymphocytes In an initial study patients in an earlier stage of HIV-1 infection tended to tolerate SC IL-2 better than those with more advanced infections and those with higher baseline CD4 counts tended to derive the greatest benefit
Detailed Description:
Interleukin-2 is a protein that is naturally produced by lymphocytes In an initial study patients in an earlier stage of HIV-1 infection tended to tolerate SC IL-2 better than those with more advanced infections and those with higher baseline CD4 counts tended to derive the greatest benefit
Patients are randomized to one of four treatment arms patients receive either low-dose or high-dose SC IL-2 for 5 days either on a monthly or bimonthly schedule for approximately 6 months
Patients are randomized to one of four treatment arms patients receive either low-dose or high-dose SC IL-2 for 5 days either on a monthly or bimonthly schedule for approximately 6 months
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 |
|---|---|---|---|
| IL-2 SC | None | None | None |
| 93-I-0205 | None | None | None |