Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00489385
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2007-06-20
Brief Title:
An Open Label Non-Randomized Dose Escalating Trial to Assess Safety and Tolerability of Alb-Interferon Alfa 2b Every Two Weeks With Ribavirin Among HIVHCV Coinfected Individuals
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
An Open Label Non-Randomized Trial to Assess Safety and Tolerability of Alb-Interferon Alfa 2b Every Two Weeks With Ribavirin Among HIVHCV Coinfected Individuals
Status:
COMPLETED
Status Verified Date:
2012-01-25
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 determine if Albumin-linked interferon Albinterferon alfa-2b every 2 weeks is safe and tolerated by patients infected by both hepatitis C virus HCV and human immunodeficiency virus HIV This is a new medication developed for HCV It may help the immune system fight infections especially those caused by viruses Albinterferon alfa-2b appears quite similar to other interferons in side effects and action in controlling HCV
Patients ages 18 and older who are infected with HCV genotype 1 are HIV positive are infected with HCV and have evidence of HCV-induced liver disease and who are not pregnant or breast feeding may be eligible for this study Many visits to NIH over a 76-week period are required There will be collection of blood and urine pregnancy test and tests of HCV in the blood A liver biopsy is required before start of the study if patients have not had one within 1 year Another is done at the end of 72 weeks An eye exam is done before start of the study and repeated later An optional procedure called automated pheresis is done at the study beginning Researchers can study patients immunity to control HCV Blood is drawn through a needle in an arm vein and spun in a machine to separate the desired blood component Remaining blood is returned to the patient
Patients will receive Albinterferon alfa-2b at a dose of 900 mcg every 2 weeks for 48 weeks by injection under the skin Ribavirin is given at 1000 mg or 1200 mg by mouth twice daily depending on a patients weight Side effects of Albinterferon alfa-2b are fatigue headache joint and muscle pain and sleeplessness The major side effect of ribavirin is anemia Visits ranging from week 3 to 44 will determine the safety of Albinterferon alfa-2b and ribavirin and to see effects on reducing the HCV viral load For weeks 48 52 56 64 72 and 76 patients will return for a clinic visit and blood tests At week 72 an abdominal ultrasound and liver biopsy are done Week 76 includes discussion of biopsy results
Patients ages 18 and older who are infected with HCV genotype 1 are HIV positive are infected with HCV and have evidence of HCV-induced liver disease and who are not pregnant or breast feeding may be eligible for this study Many visits to NIH over a 76-week period are required There will be collection of blood and urine pregnancy test and tests of HCV in the blood A liver biopsy is required before start of the study if patients have not had one within 1 year Another is done at the end of 72 weeks An eye exam is done before start of the study and repeated later An optional procedure called automated pheresis is done at the study beginning Researchers can study patients immunity to control HCV Blood is drawn through a needle in an arm vein and spun in a machine to separate the desired blood component Remaining blood is returned to the patient
Patients will receive Albinterferon alfa-2b at a dose of 900 mcg every 2 weeks for 48 weeks by injection under the skin Ribavirin is given at 1000 mg or 1200 mg by mouth twice daily depending on a patients weight Side effects of Albinterferon alfa-2b are fatigue headache joint and muscle pain and sleeplessness The major side effect of ribavirin is anemia Visits ranging from week 3 to 44 will determine the safety of Albinterferon alfa-2b and ribavirin and to see effects on reducing the HCV viral load For weeks 48 52 56 64 72 and 76 patients will return for a clinic visit and blood tests At week 72 an abdominal ultrasound and liver biopsy are done Week 76 includes discussion of biopsy results
Detailed Description:
Hepatitis C infection occurs in one-third of all human immunodeficiency virus HIV-infected individuals Liver disease has become more significant among subjects coinfected with HIV and hepatitis C virus HCV Several studies have shown that coinfected individuals develop earlier and more severe liver disease Pegylated interferon alpha with ribavirin RBV has become the therapy of choice for HCV among people with HCV alone However pegylated interferon with RBV therapy for HIVHCV coinfected subjects results in only modest cure rates This is an open-label non-randomized prospective trial to assess safety and tolerability of Alb-IFN interferon alpha genetically fused to human serum albumin 900 mcg every 2 weeks Q2w with daily RBV among HIVHCV coinfected individuals Twenty-five subjects who are infected with both HIV and HCV and who also have evidence of chronic hepatitis but who are na ve to anti-HCV treatment will receive Alb-IFN 900 mcg Q2w together with a standard daily dose of RBV for 48 weeks These subjects will be monitored for Alb-IFN serum concentration level HCV viral load HIV viral load and CD4 counts and will undergo a baseline liver biopsy and another optional liver biopsy at the end of 72 weeks The results of the study will enable us to better delineate the efficacy of Alb-IFN in suppressing the hepatitis C virus in HIVHCV coinfected subjects This will be important given the current low cure rate of HCV among HIV coinfected individuals
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 |
|---|---|---|---|
| 07-I-0001 | None | None | None |