Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00015652
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2001-04-26
Brief Title:
Interleukin-2 IL-2 Pegylated Interferon PEG-IFN Alfa-2b and Ribavirin RBV Treatment in Patients With Hepatitis C and HIV Coinfection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Pilot Study of Low Dose Interleukin-2 IL-2 With the Addition of Pegylated Interferon PEG-IFN Alfa-2b and Ribavirin RBV for the Treatment of Hepatitis C Infection in Subjects With HIV Coinfection
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:
This study will test the safety and effectiveness of a new treatment for hepatitis C HCV in patients who also have HIV
The usual treatment for HCV in people who are not HIV-infected is interferon-alfa IFN with ribavirin RBV an approved treatment by the Food and Drug Administration FDA This study will use a new longer acting form of IFN called PEG-IFN alfa-2b PEG-IFN alfa-2b is approved by the FDA for use in treating HCV but has not yet been approved for use with RBV This study also will use IL-2 which is a substance that the body naturally produces People with HIV infection usually do not make enough IL-2 IL-2 is being tested in this study to see if it will boost the immune systems response to HCV The FDA has approved IL-2 for the treatment of some cancers
The usual treatment for HCV in people who are not HIV-infected is interferon-alfa IFN with ribavirin RBV an approved treatment by the Food and Drug Administration FDA This study will use a new longer acting form of IFN called PEG-IFN alfa-2b PEG-IFN alfa-2b is approved by the FDA for use in treating HCV but has not yet been approved for use with RBV This study also will use IL-2 which is a substance that the body naturally produces People with HIV infection usually do not make enough IL-2 IL-2 is being tested in this study to see if it will boost the immune systems response to HCV The FDA has approved IL-2 for the treatment of some cancers
Detailed Description:
HCV infection is an increasingly important clinical problem in patients infected with HIV In HIV-uninfected patients with acute HCV infection the presence of vigorous T-cell proliferative responses to HCV proteins is associated with normalization of serum transaminase levels and viral clearance Furthermore early results suggest IL-2 may improve transaminase levels in HCVHIV patients These observations provide the rationale for an immune-based therapeutic approach to HCVHIV coinfection This study explores the use of initial immunostimulatory therapy with IL-2 followed by the addition of antiviral therapy with PEG-IFN alfa-2b and RBV as a possible synergistic approach to treatment
Patients receive IL-2 for 12 weeks followed by the addition of PEG-IFN alfa-2b and RBV at the Week 12 visit Patients remain on IL-2 PEG-IFN alfa-2b and RBV for an additional 48 weeks At Week 60 all study treatment is permanently discontinued and patients continue to be evaluated through Week 84 Toxicity or intolerance is evaluated Data is collected on biochemical and virologic responses
Patients receive IL-2 for 12 weeks followed by the addition of PEG-IFN alfa-2b and RBV at the Week 12 visit Patients remain on IL-2 PEG-IFN alfa-2b and RBV for an additional 48 weeks At Week 60 all study treatment is permanently discontinued and patients continue to be evaluated through Week 84 Toxicity or intolerance is evaluated Data is collected on biochemical and virologic 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 |
|---|---|---|---|
| ACTG A5088 | Registry Identifier | DAIDS ES Registry Number | None |
| AACTG A5088 | None | None | None |
| 10676 | REGISTRY | None | None |