Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000889
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
A Study to Evaluate the Effects of Giving Interleukin-2 IL-2 Plus Anti-HIV Therapy to HIV-Positive Patients With CD4 Cell Counts of at Least 350 Cellsmm3
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Open-Label Phase II Study of Subcutaneous Interleukin-2 Proleukin Plus Antiretroviral Therapy vs Antiretroviral Therapy Alone in Patients With HIV Infection and at Least 350 CD4 Cellsmm3
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 demonstrate the safety and tolerability of subcutaneously administered interleukin-2 IL-2 plus antiretrovirals in patients with HIV infection and CD4 counts of 350 cellsmm3 or more To demonstrate the immunological efficacy of subcutaneous IL-2 therapy plus antiretroviral therapy relative to antiretroviral therapy alone
IL-2 given through injection under the skin in combination with anti-HIV therapy can increase CD4 cell counts This study examines 3 doses of IL-2 in order to determine the safest and most effective dose to use
IL-2 given through injection under the skin in combination with anti-HIV therapy can increase CD4 cell counts This study examines 3 doses of IL-2 in order to determine the safest and most effective dose to use
Detailed Description:
Interleukin-2 administered subcutaneously in combination with antiretrovirals results in increases in CD4 cell count that might impact upon HIV disease progression A Phase III trial involving large numbers of HIV-positive patients is the next step in the development process To develop appropriate clinical experience with the combination this Phase II trial will allow administration of IL-2 plus antiretroviral therapy to a small number of patients in sites being considered for the Phase III trial
Patients are randomized to control therapy with antiretrovirals alone 36 patients or antiretrovirals plus IL-2 given subcutaneously every 12 hours for 5 days every 8 weeks Three doses of IL-2 are studied with 12 patients evaluated at each dose
If at least 9 of the first 12 patients complete the 5-day dosing period without dose-limiting toxicities the next 12 patients randomized are treated with the next higher dose if this dose is tolerated the last 12 patients randomized receive the highest study dose Patients enrolled at the first two doses of IL-2 who complete three courses have their dose escalated to a maximum of the highest dose
Patients are randomized to control therapy with antiretrovirals alone 36 patients or antiretrovirals plus IL-2 given subcutaneously every 12 hours for 5 days every 8 weeks Three doses of IL-2 are studied with 12 patients evaluated at each dose
If at least 9 of the first 12 patients complete the 5-day dosing period without dose-limiting toxicities the next 12 patients randomized are treated with the next higher dose if this dose is tolerated the last 12 patients randomized receive the highest study dose Patients enrolled at the first two doses of IL-2 who complete three courses have their dose escalated to a maximum of the highest dose
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 |
|---|---|---|---|
| SQIL-2 Argentina | Registry Identifier | DAIDS ES | None |
| 10467 | REGISTRY | None | None |
| SQ 1 ARG | None | None | None |