Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00078442
Status:
COMPLETED
Last Update Posted:
2009-08-07
First Post:
2004-02-25
Brief Title:
Safety and Tolerability of Pegylated Interferon PEG-IFN Alfa-2a in HIV Infected People
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase II Open-Label Pilot Trial of the Antiretroviral Activity Safety and Tolerability of Pegylated Interferon Alfa-2A 40KD PegasysTM in HIV-1 Infected Subjects
Status:
COMPLETED
Status Verified Date:
2009-08
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:
Recombinant interferon IFN may be useful in the treatment of HIV However the high doses of IFN necessary to keep HIV under control limit its use due to toxic side effects The purpose of this study is to test the safety and tolerability of weekly recombinant pegylated interferon PEG-IFN alfa-2a in HIV infected people who are currently on antiretroviral therapy ART interruption or who have not started taking anti-HIV drugs
Detailed Description:
IFN is an immune response enhancer and is produced in the body in response to viral infection PEG-IFN may have less harmful side effects than non-pegylated IFN Recombinant PEG-IFN alfa-2a is a synthetic version of IFN and is used in hepatitis C virus treatment PEG-IFN alfa-2a has demonstrated potentially useful antiviral properties in HIV treatment however due to the high doses that must be administered to maintain viral suppression toxicity especially to the blood is a concern This study will evaluate the safety tolerability and antiretroviral activity of PEG-IFN alfa-2a in HIV infected patients who have received ART in the past but are currently off ART or who are ART naive
The study will last 18 weeks Participants will receive weekly injections of 180 mcg PEG-IFN alfa-2a at the clinic for 12 weeks After Week 12 participants will be followed off-treatment until Week 18 Physical exams will be performed weekly Blood collection to monitor viral load PEG-IFN alfa-2a serum levels and CD4 and CD8 counts will be conducted at selected weeks during the study Filgrastim will be given to patients who exhibit neutropenic toxicity
The study will last 18 weeks Participants will receive weekly injections of 180 mcg PEG-IFN alfa-2a at the clinic for 12 weeks After Week 12 participants will be followed off-treatment until Week 18 Physical exams will be performed weekly Blood collection to monitor viral load PEG-IFN alfa-2a serum levels and CD4 and CD8 counts will be conducted at selected weeks during the study Filgrastim will be given to patients who exhibit neutropenic toxicity
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 |
|---|---|---|---|
| DAIDS-ES ID 10013 | None | None | None |