Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00018031
Status:
COMPLETED
Last Update Posted:
2014-10-01
First Post:
2001-06-27
Brief Title:
Peginterferon Alpha-2b And Ribavirin to Treat Hepatitis C in HIV-Infected Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Non-Randomized Open Label Study to Assess Hepatitis C Viral Kinetics in Predicting the Clinical Response in Patients With Hepatitis C Infection Coinfected With HIV-1 Treated With Peginterferon Alpha-2b and Ribavirin
Status:
COMPLETED
Status Verified Date:
2014-09
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:
HEPCPR
Brief Summary:
This study will evaluate the safety and effectiveness of combination therapy with peginterferon alfa-2b and ribavirin for treating hepatitis C virus HCV infection in HIV-infected patients In studies of patients with hepatitis C alone interferon alfa-2b plus ribavirin treatment eradicated the HCV in almost half the patients Peginterferon alfa-2b is a compound that results from attaching a polyethylene glycol molecule to interferon alfa-2b This compound stays in the blood longer than unmodified interferon alfa-2b causing a higher blood concentration and thus maintaining activity against the hepatitis C virus
HIV-infected patients 21 years of age and older with chronic hepatitis C infection and a viral load greater than 2000 copiesmL may be eligible for this 2 12-year study Candidates will be screened with blood and urine tests and possibly a liver biopsy if a recent one is not available The liver biopsy is done to determine the severity of liver disease For this test patients are admitted to the NIH Clinical Center for 1 to 2 days A sedative is injected into an arm vein the skin in the area over the biopsy site is numbed with a local anesthetic and a needle is inserted rapidly into and out of the liver to obtain a small tissue sample The patient remains in the hospital overnight for monitoring A chest X-ray electrocardiogram EKG and liver ultrasound are also done Within 4 weeks of the screening tests candidates who appear eligible for the study will have a physical examination medical history and repeat blood tests Women who can become pregnant will have serial pregnancy tests throughout the study
Patients who meet the study criteria and decide to participate will begin treatment with weekly injections under the skin of peginterferon alfa-2b and take ribavirin pills twice a day by mouth In addition patients will continue to take all other medications prescribed by their doctor Clinic visits will be scheduled as follows
Days 1 3 5 7 10 and 21 - Blood will be drawn for safety tests and to measure blood levels of HIV and HCV
Weeks 2 4 8 12 16 20 24 28 32 36 40 44 52 56 and 64 - Blood and urine tests will be done to determine the side effects of treatment and its effect on the HCV infection
Week 48 or end of treatment - Treatment will stop after 48 weeks At this time or earlier for those who do not complete the 48 weeks patients will return to the clinic for a routine test
HIV-infected patients 21 years of age and older with chronic hepatitis C infection and a viral load greater than 2000 copiesmL may be eligible for this 2 12-year study Candidates will be screened with blood and urine tests and possibly a liver biopsy if a recent one is not available The liver biopsy is done to determine the severity of liver disease For this test patients are admitted to the NIH Clinical Center for 1 to 2 days A sedative is injected into an arm vein the skin in the area over the biopsy site is numbed with a local anesthetic and a needle is inserted rapidly into and out of the liver to obtain a small tissue sample The patient remains in the hospital overnight for monitoring A chest X-ray electrocardiogram EKG and liver ultrasound are also done Within 4 weeks of the screening tests candidates who appear eligible for the study will have a physical examination medical history and repeat blood tests Women who can become pregnant will have serial pregnancy tests throughout the study
Patients who meet the study criteria and decide to participate will begin treatment with weekly injections under the skin of peginterferon alfa-2b and take ribavirin pills twice a day by mouth In addition patients will continue to take all other medications prescribed by their doctor Clinic visits will be scheduled as follows
Days 1 3 5 7 10 and 21 - Blood will be drawn for safety tests and to measure blood levels of HIV and HCV
Weeks 2 4 8 12 16 20 24 28 32 36 40 44 52 56 and 64 - Blood and urine tests will be done to determine the side effects of treatment and its effect on the HCV infection
Week 48 or end of treatment - Treatment will stop after 48 weeks At this time or earlier for those who do not complete the 48 weeks patients will return to the clinic for a routine test
Detailed Description:
Hepatitis C infection occurs in one-third of all HIV-infected individuals Liver disease has become more clinically significant among patients coinfected with HIV and HCV Several studies have shown that coinfected individuals develop earlier and severe liver disease Interferon with ribavirin has become the therapy of choice among people with non-genotype 1a This is a pilot study to address the relationship of clinical response to combination therapy to the virologic and immunologic parameters The study will also address the safety and efficacy of the peginterferon alfa-2b among HIV- infected individuals The predictive ability of baseline HCV viral load rate of decline of HCV viral load HIV viral load and CD4 counts to the clinical response of chronic hepatitis to peginterferon and ribavirin will also be studied Approximately sixty patients who are infected with both HIV and HCV and also have evidence of fibrosis will receive peginterferon alfa-2b and ribavirin for 48 weeks In order to enroll sixty patients for this study we will be screening a total of 180 patients During the 72 weeks study these patients will be monitored for HCV viral load and other HIV viral load and CD4 counts Viral kinetics will also be monitored closely and the slope of second slower phase decline of HCV viral load which corresponds to the rate of infected cell death presumably may lead to sustained hepatitis C virologic response The results of the study will enable us to better delineate the possible predictors of sustained response to peginterferon and ribavirin The safety and tolerability of a combination therapy with peginterferon and ribavirin among HIV-infected individuals on antiretroviral therapy will further define the standard therapy of chronic hepatitis C in HIV-infected 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 |
|---|---|---|---|
| 01-I-0194 | None | None | None |