Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006325
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2000-10-02
Brief Title:
Safety Tolerability and Anti-HIV Activity of PEG-Intron in HIV-Positive Children
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Safety Tolerability Antiviral Activity and Pharmacokinetics of PEG-Intron in HIV-1 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 see if PEG-Intron is safe and tolerated when given to children to see how much gets into the blood and how long it stays in the blood and to see how well it works to reduce viral load level of HIV in the blood
PEG-Intron is an experimental drug that works differently than other anti-HIV medications It decreases the ability of HIV to infect the T cells a special type of cell that helps fight infection PEG-Intron has been approved by the Food and Drug Administration FDA to treat hepatitis C in adults but in this study it is being used as an investigational agent for the treatment of HIVAIDS It has not been tested in children before and experience with PEG-Intron in adults is limited This protocol has been changed to reflect FDA approval of PEG-Intron for treating hepatitic C in adults
PEG-Intron is an experimental drug that works differently than other anti-HIV medications It decreases the ability of HIV to infect the T cells a special type of cell that helps fight infection PEG-Intron has been approved by the Food and Drug Administration FDA to treat hepatitis C in adults but in this study it is being used as an investigational agent for the treatment of HIVAIDS It has not been tested in children before and experience with PEG-Intron in adults is limited This protocol has been changed to reflect FDA approval of PEG-Intron for treating hepatitic C in adults
Detailed Description:
The current optimal clinical management of HIV infection involves therapy with combinations of nucleoside and nonnucleoside reverse transcriptase inhibitors and HIV protease inhibitors These regimens though effective do not completely eliminate HIV and the development of drug resistance is a major clinical problem Interferons have been proposed as a possible treatment of HIV Interferon-alfa inhibits HIV replication in vitro and HIV-infected patients appear to have reduced production of interferons Previous short-term clinical studies in adults showed anti-HIV activity although there were safety and tolerability problems associated with the higher dose regimens used This study will utilize a rising multiple-dose design to assess the safety tolerability and pharmacokinetics of single and multiple doses of PEG-Intron in HIV-infected children
In a dose-escalation study patients add weekly PEG-Intron to their antiretroviral therapy for up to 6 weeks The first 2 doses are received in the clinic where parentsguardians are trained to administer injections and succeeding doses are given at home
Patients are enrolled from 2 cohorts An older cohort of ages 2 to 16 years receives PEG-Intron at the lowest drug level If the dose is tolerated patients are added and if safety criteria are met patients are enrolled in the next higher dose level The dose level will be increased similarly for up to 4 doses An optimal dose level is chosen
Cohort II patients are a younger group ranging from 3 months to under 2 years of age Patients initially receive the next lower PEG-Intron dose to the optimal dose identified in Cohort I AS PER AMENDMENT 072301 or 1 microgkg if the optimal dose proves to be 1 microgkg If this dose is safely tolerated additional patients are added If this dose level meets safety criteria patients are enrolled to receive the optimal dose level Patients are evaluated with the same safety criteria as Cohort I Patients in both cohorts who have at least a 05 log reduction in HIV RNA at 28 days of treatment are offered continued treatment for a total of 60 weeks
In a dose-escalation study patients add weekly PEG-Intron to their antiretroviral therapy for up to 6 weeks The first 2 doses are received in the clinic where parentsguardians are trained to administer injections and succeeding doses are given at home
Patients are enrolled from 2 cohorts An older cohort of ages 2 to 16 years receives PEG-Intron at the lowest drug level If the dose is tolerated patients are added and if safety criteria are met patients are enrolled in the next higher dose level The dose level will be increased similarly for up to 4 doses An optimal dose level is chosen
Cohort II patients are a younger group ranging from 3 months to under 2 years of age Patients initially receive the next lower PEG-Intron dose to the optimal dose identified in Cohort I AS PER AMENDMENT 072301 or 1 microgkg if the optimal dose proves to be 1 microgkg If this dose is safely tolerated additional patients are added If this dose level meets safety criteria patients are enrolled to receive the optimal dose level Patients are evaluated with the same safety criteria as Cohort I Patients in both cohorts who have at least a 05 log reduction in HIV RNA at 28 days of treatment are offered continued treatment for a total of 60 weeks
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 |
|---|---|---|---|
| 11652 | REGISTRY | DAIDS ES Registry Number | None |
| PACTG P1017 | None | None | None |
| ACTG P1017 | None | None | None |