Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000849
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
A Study to Test the Safety of Recombinant Interleukin-2 rIL-2 in HIV-Infected Children
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase III Trial of Recombinant Interleukin-2 In Symptomatic Human Immunodeficiency Virus-Infected Children
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 safety and maximum tolerated dose the highest dose that can be given safely of recombinant Interleukin-2 rIL-2 in HIV-infected children This study also evaluates the effect of rIL-2 on the immune system of these patients
IL-2 is a substance naturally produced by the bodys white blood cells that plays an important role in helping the body fight infection HIV-infected patients do not produce enough IL-2 and it is hoped that the use of rIL-2 may improve immune system function in these patients First it is necessary to determine the safety and effectiveness of this drug in HIV-infected children
IL-2 is a substance naturally produced by the bodys white blood cells that plays an important role in helping the body fight infection HIV-infected patients do not produce enough IL-2 and it is hoped that the use of rIL-2 may improve immune system function in these patients First it is necessary to determine the safety and effectiveness of this drug in HIV-infected children
Detailed Description:
According to study records IL-2 has not been tested in HIV-infected children Experience with IL-2 in pediatric populations is extremely limited Pahwa et al gave 30000 unitskg daily IV to a child with severe combined immunodeficiency This dose was well tolerated and the patient improved clinically as well as immunologically Part A is necessary to determine the maximum tolerated dose of IL-2 in infected children Part B will determine the efficacy of the maximum tolerated dose in infected children
Part A Children will receive rIL-2 intravenously for 5 days every 8 weeks for 3 cycles The study will enroll 4 patients in each of 3 dose levels Dose escalation may occur if all 4 patients in a dose level tolerate therapy without evidence of Grade 3 or higher toxicity If 1 of 4 subjects in any dose level experiences at least Grade 3 toxicity 2 additional patients will be enrolled in that dose level If 1 of these 2 additional patients experiences at least Grade 3 toxicity dose escalation will not proceed NOTE Once Part A is completed and the maximum tolerated dose is established children who participated in Part A and received less than the maximum tolerated dose will be offered additional therapy consisting of 3 cycles of rIL-2 at the maximum tolerated dose
Part B Children will receive rIL-2 intravenously at the maximum tolerated dose established in part A Treatment will be given for 5 days every 8 weeks for 3 cycles AS PER AMENDMENT 6498 Children will receive rIL-2 intravenously at the lowest dose for 5 days every 8 weeks for 6 cycles Patients who received this dose in part A will also be offered this regimen
Part A Children will receive rIL-2 intravenously for 5 days every 8 weeks for 3 cycles The study will enroll 4 patients in each of 3 dose levels Dose escalation may occur if all 4 patients in a dose level tolerate therapy without evidence of Grade 3 or higher toxicity If 1 of 4 subjects in any dose level experiences at least Grade 3 toxicity 2 additional patients will be enrolled in that dose level If 1 of these 2 additional patients experiences at least Grade 3 toxicity dose escalation will not proceed NOTE Once Part A is completed and the maximum tolerated dose is established children who participated in Part A and received less than the maximum tolerated dose will be offered additional therapy consisting of 3 cycles of rIL-2 at the maximum tolerated dose
Part B Children will receive rIL-2 intravenously at the maximum tolerated dose established in part A Treatment will be given for 5 days every 8 weeks for 3 cycles AS PER AMENDMENT 6498 Children will receive rIL-2 intravenously at the lowest dose for 5 days every 8 weeks for 6 cycles Patients who received this dose in part A will also be offered this regimen
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 |
|---|---|---|---|
| PACTG 299 | Registry Identifier | DAIDS ES Registry Number | None |
| 11275 | REGISTRY | None | None |