Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001131
Status:
COMPLETED
Last Update Posted:
2015-05-15
First Post:
2000-01-17
Brief Title:
Effectiveness of Interleukin-2 IL-2 Plus Anti-HIV Therapy in HIV-Positive Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Procedure for Initiation Administration and Discontinuation of Interleukin-2 IL-2 Therapy in Conjunction With Highly Active Antiretroviral Therapy
Status:
COMPLETED
Status Verified Date:
2013-09
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:
The purpose of this study is to find out if the immune systems of HIV-positive patients can be improved by treatment with anti-HIV medications plus interleukin-2 IL-2 in the early stages of HIV infection
IL-2 is a protein found naturally in the blood that can help boost the immune system HIV spreads throughout the body by invading CD4 cells which are cells of the immune system that fight infection Doctors hope that adding IL-2 to a current anti-HIV drug combination can help restore the CD4 cell count and the immune functions This study will look at how the HIV virus acts during the early stages of HIV infection how the immune system responds to HIV and what impact early treatment with anti-HIV medications has on the course of HIV infection
IL-2 is a protein found naturally in the blood that can help boost the immune system HIV spreads throughout the body by invading CD4 cells which are cells of the immune system that fight infection Doctors hope that adding IL-2 to a current anti-HIV drug combination can help restore the CD4 cell count and the immune functions This study will look at how the HIV virus acts during the early stages of HIV infection how the immune system responds to HIV and what impact early treatment with anti-HIV medications has on the course of HIV infection
Detailed Description:
At the time of initial HIV infection CD4 cells are susceptible to infection and the virus infects many T cells during the first 4 to 6 weeks Many of these infected cells subsequently maintain the virus in a latent state Immune reconstitution with daily low-dose IL-2 therapy is intended to correct or improve the deficiency in CD4 cells while maintaining a high frequency of CD8 HIV-specific CTL and increasing natural killer NK cells After a year of HAART plus IL-2 it may be possible to discontinue HAART while maintaining IL-2 stimulatory therapy and the immune reactivity repaired and stimulated by IL-2 should be able to contain the virus and maintain latency
Patients are randomized to add IL-2 to their current HAART regimen or simply to remain on their current HAART regimen IL-2 therapy is initiated at Month 3 of HAART IL-2 is injected subcutaneously daily for 9 months in addition to HAART After completion of this 1-year treatment period patients are evaluated for discontinuation of HAART Patients with a viral load below 50 copiesml throughout HAART plus IL-2 a CD4 count of at least 500 cellsmm3 and no onset of opportunistic infections may have HAART discontinued and IL-2 continued as monotherapy for an additional 6 months After completing 6 months of IL-2 monotherapy eligible patients may have IL-2 therapy discontinued
Patients are randomized to add IL-2 to their current HAART regimen or simply to remain on their current HAART regimen IL-2 therapy is initiated at Month 3 of HAART IL-2 is injected subcutaneously daily for 9 months in addition to HAART After completion of this 1-year treatment period patients are evaluated for discontinuation of HAART Patients with a viral load below 50 copiesml throughout HAART plus IL-2 a CD4 count of at least 500 cellsmm3 and no onset of opportunistic infections may have HAART discontinued and IL-2 continued as monotherapy for an additional 6 months After completing 6 months of IL-2 monotherapy eligible patients may have IL-2 therapy discontinued
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 |
|---|---|---|---|
| AIEDRP AI-06-001 | None | None | None |