Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000857
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
A Study to Evaluate the Effects of Interleukin-12 rhIL-12 in HIV-Positive Patients With CD4 Cell Counts Less Than 50 Cellsmm3 or 300-500 Cellsmm3
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase I Double-Blind Randomized Placebo-Controlled Trial of Recombinant Human Interleukin-12 rhIL-12 in HIV-Infected Subjects With Less Than 50 CD4 T Cells and Subjects With 300-500 CD4 T Cells
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 the tolerance and effectiveness of rhIL-12 in HIV-positive patients with CD4 cell counts less than 50 cellsmm3 versus 300-500 cellsmm3 This study will look at the ability of rhIL-12 to boost the immune system against HIV and HIV-associated bacterial infections in these patients
IL-12 is found naturally in the body and rhIL-12 is the commercially produced version IL-12 may enhance anti-HIV immune system activity by increasing the number of cells that fight infection IL-12 may also increase the bodys ability to fight bacterial infections such as Mycobacterium avium complex MAC
IL-12 is found naturally in the body and rhIL-12 is the commercially produced version IL-12 may enhance anti-HIV immune system activity by increasing the number of cells that fight infection IL-12 may also increase the bodys ability to fight bacterial infections such as Mycobacterium avium complex MAC
Detailed Description:
IL-12 has a number of effects in vitro that could be relevant to HIV disease including promotion of TH1 cell development enhancement of HIV-specific T cell responses in cells from subjects with AIDS and of particular relevance to MAC disease increasing secretion of cytotoxic cytokines such as IFN-gamma from both T lymphocytes and NK cells
Part A 36 patients with less than 50 CD4 cellsmm3
Patients are randomized within one of three sequential dose cohorts and receive either rhIL-12 or matching placebo by subcutaneous injection twice weekly for four weeks Eligible patients will participate in only 1 of the 3 dosing cohorts Dose escalation to a new cohort of patients in Part A will occur only if all 3 of the following occur
1 At least 9 patients in the rhIL-12 arm have been enrolled in the current dose group and have either been on study drug for at least 4 weeks temporary discontinuation is allowed or have permanently discontinued study drug due to a primary toxicity endpoint
2 AS PER AMENDMENT 61697 Fewer than 2 of the 12 patients receiving rhIL-12 at 30 or 100 ngkg have had a primary toxicity endpoint 3 Adequate data from a Genetics InstituteWyeth Ayerst-sponsored dose escalation trial have been obtained and analyzed to demonstrate the safety of the dose to be administered to the next cohort
Note If 3 or more patients in the rhIL-12 arm of a given dose in Part A experience a primary toxicity endpoint then accrual and further drug administration will be discontinued
AS PER AMENDMENT 61697 If a cohort has exactly two patients in the rhIL-12 arm that experience a primary toxicity endpoint then the next cohort receives study drug at the same dose as the current cohort but administered only once a week If a cohort receiving study drug administered once a week has at least two subjects experience a primary toxicity endpoint then further drug administration in Part A is stopped Any cohort that receives study drug once a week is the last cohort in Part A no further dose escalation is performed
Part B 18 subjects with 300-500 CD4 cellsmm3
Patients are randomized to receive either the maximum tolerated dose determined in Part A of rhIL-12 or matching placebo subcutaneously twice a week for 4 weeks
AS PER AMENDMENT 012999 Because of slow accrual for cohort 3 of Part A concurrent enrollment will begin for Part B while cohort 3 of Part A is completed There will be no further dose escalation in Part A Part A will remain open to accrual until the final enrollee to Part B completes 4 weeks of study treatment For Part B 27 patients will be randomized with equal probability to one of two rhIL-12 doses or placebo Semiweekly injections are given for 4 weeks
Part A 36 patients with less than 50 CD4 cellsmm3
Patients are randomized within one of three sequential dose cohorts and receive either rhIL-12 or matching placebo by subcutaneous injection twice weekly for four weeks Eligible patients will participate in only 1 of the 3 dosing cohorts Dose escalation to a new cohort of patients in Part A will occur only if all 3 of the following occur
1 At least 9 patients in the rhIL-12 arm have been enrolled in the current dose group and have either been on study drug for at least 4 weeks temporary discontinuation is allowed or have permanently discontinued study drug due to a primary toxicity endpoint
2 AS PER AMENDMENT 61697 Fewer than 2 of the 12 patients receiving rhIL-12 at 30 or 100 ngkg have had a primary toxicity endpoint 3 Adequate data from a Genetics InstituteWyeth Ayerst-sponsored dose escalation trial have been obtained and analyzed to demonstrate the safety of the dose to be administered to the next cohort
Note If 3 or more patients in the rhIL-12 arm of a given dose in Part A experience a primary toxicity endpoint then accrual and further drug administration will be discontinued
AS PER AMENDMENT 61697 If a cohort has exactly two patients in the rhIL-12 arm that experience a primary toxicity endpoint then the next cohort receives study drug at the same dose as the current cohort but administered only once a week If a cohort receiving study drug administered once a week has at least two subjects experience a primary toxicity endpoint then further drug administration in Part A is stopped Any cohort that receives study drug once a week is the last cohort in Part A no further dose escalation is performed
Part B 18 subjects with 300-500 CD4 cellsmm3
Patients are randomized to receive either the maximum tolerated dose determined in Part A of rhIL-12 or matching placebo subcutaneously twice a week for 4 weeks
AS PER AMENDMENT 012999 Because of slow accrual for cohort 3 of Part A concurrent enrollment will begin for Part B while cohort 3 of Part A is completed There will be no further dose escalation in Part A Part A will remain open to accrual until the final enrollee to Part B completes 4 weeks of study treatment For Part B 27 patients will be randomized with equal probability to one of two rhIL-12 doses or placebo Semiweekly injections are given for 4 weeks
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 |
|---|---|---|---|
| 11299 | REGISTRY | DAIDS ES Registry Number | None |