Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001116
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
1999-11-02
Brief Title:
A Study to Evaluate the Ability of TNFRFc to Decrease the Amount of IL-6 Interleukin-6 and TNF-alpha Tumor Necrosis Factor 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:
Effect of Recombinant Human Soluble Tumor Necrosis Factor Receptor TNFRFc on Interleukin-6 IL-6 Tumor Necrosis Factor-Alpha TNF-alpha and Markers of Immune Activation in HIV-Infected Subjects
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:
The purpose of this study is to determine if TNFRFc a molecule that attaches to TNF can lower the amount of IL-6 in HIV-positive patients This study will also examine the effect of TNFRFc on TNF-alpha IL-6 and TNF-alpha are 2 substances produced by the immune system that may increase the rate of HIV replication
IL-6 and TNF-alpha are produced naturally by the body High levels of TNF-alpha lead to increased IL-6 production and increased HIV replication therefore helping the virus infect the body HIV-positive patients who receive IL-2 interleukin-2 a protein that helps the immune system fight infection tend to have higher levels of IL-6 and TNF-alpha than patients not receiving IL-2 These increased levels may contribute to some of the flu-like symptoms related to IL-2 administration TNFRFc can neutralize TNF-alpha to decrease the action of TNF-alpha and in turn decrease the amount of IL-6 in the body TNFRFc may therefore have a role in the treatment of HIV disease or in relieving some of the symptoms related to IL-2 administration
IL-6 and TNF-alpha are produced naturally by the body High levels of TNF-alpha lead to increased IL-6 production and increased HIV replication therefore helping the virus infect the body HIV-positive patients who receive IL-2 interleukin-2 a protein that helps the immune system fight infection tend to have higher levels of IL-6 and TNF-alpha than patients not receiving IL-2 These increased levels may contribute to some of the flu-like symptoms related to IL-2 administration TNFRFc can neutralize TNF-alpha to decrease the action of TNF-alpha and in turn decrease the amount of IL-6 in the body TNFRFc may therefore have a role in the treatment of HIV disease or in relieving some of the symptoms related to IL-2 administration
Detailed Description:
Both Interleukin-6 IL-6 and Tumor necrosis factor-alpha TNF-alpha are substances naturally produced by the bodys immune system Evidence suggests that TNF-alpha production may be excessive or inappropriate in HIV-infected patients Elevated TNF-alpha levels can result in increased IL-6 production and possibly increased HIV replication TNFRFc is a modification of a natural substance that binds to TNF-alpha and neutralizes its activity It is postulated that TNFRFc may result in decreased activity of TNF-alpha and lower IL-6 levels HIV-infected patients who receive Interleukin-2 IL-2 have been shown to have higher TNF-alpha and IL-6 levels than those who do not receive IL-2 It is thought that these higher levels of TNF-alpha and IL-6 may contribute to some of the flu-like symptoms experienced by patients receiving IL-2 By decreasing the amount of IL-6 in the body and by decreasing the action of TNF-alpha in the body TNFRFc may have a role in the treatment of HIV disease or in alleviating some of the symptoms related to IL-2 administration
Six patients from each of the 3 treatment arms of ACTG 328 HAART alone HAART plus intravenous IV rhIL-2 and HAART plus subcutaneous SC rhIL-2 who are about to be randomized to Step II of ACTG 328 may participate in this prospective nested substudy Patients randomized to the Interleukin-2 IL-2 arms of ACTG 328 are pretreated with TNFRFc administered by infusion over 30 minutes at week 16 of ACTG 928 Course 3 Week 28 of ACTG 328 just prior to initiation of IL-2 Those randomized to the highly active antiretroviral therapy HAART only arm of ACTG 328 receive treatment with TNFRFc at Week 16 of ACTG 928 Week 28 of ACTG 328
Six patients from each of the 3 treatment arms of ACTG 328 HAART alone HAART plus intravenous IV rhIL-2 and HAART plus subcutaneous SC rhIL-2 who are about to be randomized to Step II of ACTG 328 may participate in this prospective nested substudy Patients randomized to the Interleukin-2 IL-2 arms of ACTG 328 are pretreated with TNFRFc administered by infusion over 30 minutes at week 16 of ACTG 928 Course 3 Week 28 of ACTG 328 just prior to initiation of IL-2 Those randomized to the highly active antiretroviral therapy HAART only arm of ACTG 328 receive treatment with TNFRFc at Week 16 of ACTG 928 Week 28 of ACTG 328
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 |
|---|---|---|---|
| 11498 | REGISTRY | DAIDS ES Registry Number | None |