Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004978
Status:
COMPLETED
Last Update Posted:
2021-11-05
First Post:
2000-03-10
Brief Title:
An International Study to Evaluate Recombinant Interleukin-2 in HIV Positive Patients Taking Anti-retroviral Therapy
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 III International Study of Subcutaneous Recombinant IL-2 in Patients With HIV-1 Infection and CD4 Cell Counts 300mm3 or Greater Evaluation of Subcutaneous Proleukin in a Randomized International Trial
Status:
COMPLETED
Status Verified Date:
2012-10
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:
ESPRIT
Brief Summary:
The purpose of this study is to see if it is effective to give HIV positive patients recombinant interleukin-2 rIL-2 in addition to anti-HIV therapy Patients will be followed over a minimum of 4 years to study the long-term effects of rIL-2 on their HIV disease progression
Anti-HIV therapy has been very successful in treating HIV positive patients and in keeping viral load level of HIV in the blood low However anti-HIV drugs cannot completely rid the body of the virus and the immune system is never completely restored in HIV positive patients Doctors hope that giving patients recombinant interleukin-2 rIL-2 in addition to their anti-HIV therapy will help improve their immune systems and keep them healthier over a longer period of time rIL-2 is a hormone naturally produced by the body during an immune response to a microbial infection
Anti-HIV therapy has been very successful in treating HIV positive patients and in keeping viral load level of HIV in the blood low However anti-HIV drugs cannot completely rid the body of the virus and the immune system is never completely restored in HIV positive patients Doctors hope that giving patients recombinant interleukin-2 rIL-2 in addition to their anti-HIV therapy will help improve their immune systems and keep them healthier over a longer period of time rIL-2 is a hormone naturally produced by the body during an immune response to a microbial infection
Detailed Description:
Much progress has been made in implementing potent antiretroviral therapy that is able to maximally suppress viral replication However these drug combinations do not result in viral eradication and for many patients virologic and immunologic control cannot be maintained Even among patients with apparent virologic control a ceiling effect seems to exist with failure of CD4 cell counts to rise on average more than 100 to 150 cellsmm3 at least during the first 2 years of therapy The incomplete recovery of immune function after initiation of therapy remains an obstacle in the management of HIV Preservation of immune function by direct expansion of CD4 lymphocytes with rIL-2 could represent a significant additional treatment strategy It also has been speculated recently that rIL-2 in combination with potent antiretroviral therapy may be a useful approach for purging HIV from the latently infected CD4 cells It is hoped that intervention with rIL-2 therapy in combination with antiretroviral therapy at an early stage of HIV infection can prevent CD4 T-cell depletion and result in fewer AIDS-defining illnesses than with antiretroviral therapy alone
Patients are randomized to receive subcutaneous SC rIL-2 therapy or no rIL-2 therapy All patients must be taking a regimen of combination antiretroviral treatment with the choice of therapy at the discretion of the treating clinician Antiretroviral medications are not provided by this study Recombinant IL-2 is given SC for 5 consecutive days every 8 weeks for at least 3 cycles unless toxicities or other contraindications develop After the first three cycles additional cycles are given at the discretion of each patients physician with a general goal of maintaining the patients CD4 cell count at twice the baseline level or at 1000 cellsmm3 or above for as long as possible Patients in the no rIL-2 group receive no injections Patients in both treatment groups are seen every 4 months for follow-up data collection to monitor viral load and CD4 cell counts All patients are followed for a minimum of 4 years During the trial patients in the no SC rIL-2 group are not given rIL-2 at any point However at the end of the study if rIL-2 is found to be effective in reducing the rate of disease progression AS PER AMENDMENT 121500 new and recurrent events including death all patients are offered rIL-2
Patients are randomized to receive subcutaneous SC rIL-2 therapy or no rIL-2 therapy All patients must be taking a regimen of combination antiretroviral treatment with the choice of therapy at the discretion of the treating clinician Antiretroviral medications are not provided by this study Recombinant IL-2 is given SC for 5 consecutive days every 8 weeks for at least 3 cycles unless toxicities or other contraindications develop After the first three cycles additional cycles are given at the discretion of each patients physician with a general goal of maintaining the patients CD4 cell count at twice the baseline level or at 1000 cellsmm3 or above for as long as possible Patients in the no rIL-2 group receive no injections Patients in both treatment groups are seen every 4 months for follow-up data collection to monitor viral load and CD4 cell counts All patients are followed for a minimum of 4 years During the trial patients in the no SC rIL-2 group are not given rIL-2 at any point However at the end of the study if rIL-2 is found to be effective in reducing the rate of disease progression AS PER AMENDMENT 121500 new and recurrent events including death all patients are offered rIL-2
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 |
|---|---|---|---|
| 10118 | REGISTRY | DAIDS ES Registry Number | httpsreporternihgovquickSearch3U01AI046957-05S3 |
| 5U01AI046957 | NIH | None | None |
| 00 I-0071 | None | None | None |
| 3U01AI046957-05S2 | NIH | None | None |
| 3U01AI046957-05S3 | NIH | None | None |