Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006066
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2000-07-14
Brief Title:
Interleukin-2 Plus Anti-HIV Therapy in HIV-Infected Children With Weakened Immune Systems
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 Subcutaneous IL-2 With Highly Active Antiretroviral Therapy in HIV-Infected Children With Immunosuppression
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 of a drug called interleukin-2 IL-2 given with anti-HIV therapy in children with HIV infection This study will also determine the best dose of IL-2 to give children
IL-2 is an important substance produced by the bodys white blood cells that helps the body fight infection People with HIV infection do not produce enough IL-2 It is hoped that IL-2 treatment will help boost the immune system in people with HIV infection It has not been studied very much in children and doctors need to know what doses are safe to give
IL-2 is an important substance produced by the bodys white blood cells that helps the body fight infection People with HIV infection do not produce enough IL-2 It is hoped that IL-2 treatment will help boost the immune system in people with HIV infection It has not been studied very much in children and doctors need to know what doses are safe to give
Detailed Description:
One of the challenges in effective combination therapy in HIV-infected patients is the ability to achieve immune reconstitution IL-2 is hypothesized to restore andor preserve the immune system when added to potent antiretroviral regimens This study will evaluate restoration of immune functions of CD4 cells and will also determine the best way to deliver IL-2 in a safe and effective way
Part I Patients add a 5-day course of subcutaneous IL-2 every 8 weeks for up to 48 weeks 6 cycles to their HAART therapy Three dose levels of IL-2 are administered AS PER AMENDMENT 5301 It is strongly recommended but not required that the first and second cycles of IL-2 are given in the hospital on an inpatient basis The parent or patient is trained to give the injections and has the option of administering subsequent injections at home Patients are monitored for CD4 and CD8 cell count and viral load Enrollment into Part 1 begins at the lowest dose level assuming no serious toxicities Grade 3 or higher occur patients are enrolled into higher dose levels The highest tolerated dose is established
Part 2 After the highest tolerated dose is established in Part 1 additional patients are randomized to receive HAART alone Arm 1 HAART with high-dose IL-2 Arm 2 or HAART with low-dose IL-2 Arm 3 High-dose IL-2 is given twice daily at the highest dose tolerated in Part 1 for 5 days every 8 weeks for 6 cycles Low-dose IL-2 is given once a day every day for 48 weeks For Arms 2 and 3 AS PER AMENDMENT 5301 except patients in the pharmacokinetic substudy it is strongly recommended but not required that IL-2 is given the first week on an inpatient basis by hospital personnel As in Part 1 there is the option of administering the remaining injections at home Intensive toxicity monitoring routine lymphocyte subsets and quantitative HIV RNA are performed on all patients at specified time points during the study The first 12 patients in Arms 2 and 3 have pharmacokinetic testing with frequent blood samples drawn at intervals some of which require staying up to 12 hours at the clinic Diphtheriatetanus immunizations and bacteriophage phi X174 immunizations are administered to all patients to determine antibody responses
Part I Patients add a 5-day course of subcutaneous IL-2 every 8 weeks for up to 48 weeks 6 cycles to their HAART therapy Three dose levels of IL-2 are administered AS PER AMENDMENT 5301 It is strongly recommended but not required that the first and second cycles of IL-2 are given in the hospital on an inpatient basis The parent or patient is trained to give the injections and has the option of administering subsequent injections at home Patients are monitored for CD4 and CD8 cell count and viral load Enrollment into Part 1 begins at the lowest dose level assuming no serious toxicities Grade 3 or higher occur patients are enrolled into higher dose levels The highest tolerated dose is established
Part 2 After the highest tolerated dose is established in Part 1 additional patients are randomized to receive HAART alone Arm 1 HAART with high-dose IL-2 Arm 2 or HAART with low-dose IL-2 Arm 3 High-dose IL-2 is given twice daily at the highest dose tolerated in Part 1 for 5 days every 8 weeks for 6 cycles Low-dose IL-2 is given once a day every day for 48 weeks For Arms 2 and 3 AS PER AMENDMENT 5301 except patients in the pharmacokinetic substudy it is strongly recommended but not required that IL-2 is given the first week on an inpatient basis by hospital personnel As in Part 1 there is the option of administering the remaining injections at home Intensive toxicity monitoring routine lymphocyte subsets and quantitative HIV RNA are performed on all patients at specified time points during the study The first 12 patients in Arms 2 and 3 have pharmacokinetic testing with frequent blood samples drawn at intervals some of which require staying up to 12 hours at the clinic Diphtheriatetanus immunizations and bacteriophage phi X174 immunizations are administered to all patients to determine antibody responses
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 |
|---|---|---|---|
| 10607 | REGISTRY | None | None |
| PACTG 402 | Registry Identifier | DAIDS ES Registry Number | None |