Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031343
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2002-03-02
Brief Title:
The Impact of HAART on Response to Hepatitis C Treatment in Patients Taking Peginterferon Alpha-2b and Ribavirin
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Randomized Controlled Study to Assess the Impact of Highly Active Antiretroviral Therapy to Hepatitis C Therapy in Patients Coinfected With HIV-1 and Treated With Peginterferon Alpha-2b and Ribavirin
Status:
COMPLETED
Status Verified Date:
2004-04
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 evaluate how controlling HIV infection with HAART highly active antiretroviral therapy affects the response to hepatitis C treatment with peginterferon alpha-2b and ribavirin in HIV-infected patients with chronic hepatitis C HIV worsens liver disease caused by hepatitis C Since treatment of HIV infection with HAART improves immune function it may be beneficial to start HAART before treating HCV
HIV-infected patients 18 years of age and older with chronic hepatitis C infection may be eligible for this study Patients must have an HCV viral load greater than 2000 copiesmL and a CD4 count that is either more than 500 cellsmm3 or more than 350 cellsmm3 with an HIV viral load no greater than 40000 particlesmL Candidates will be screened for current or previous diseases conditions or treatments that may exclude them from this study Screening includes a medical history and physical examination eye examination blood and urine tests chest X-ray electrocardiogram EKG liver ultrasound and possibly a liver biopsy if a recent one is not available The liver biopsy is optional and is done to determine the severity of liver disease Patients will be sedated for this test 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 Patients remain in the hospital overnight for monitoring Women of childbearing age will have a pregnancy test
Patients enrolled in the study will be randomly assigned to one of the following treatment groups 1 pegylated interferon and ribavirin for 48 weeks control group or 2 HAART for 6 months followed by 48 weeks of pegylated interferon and ribavirin
HAART group - Patients taking HAART will be followed in the clinic every 2 weeks for the first month and then monthly for the next 5 months After 6 months of HAART they will begin taking pegylated interferon and ribavirin and will follow the dosing and follow-up schedule outlined below for patients in the control group
Control group - Patients will have weekly injections under the skin of peginterferon alpha-2b and ribavirin pills daily by mouth Clinic visits will be scheduled as follows
Days 1 3 7 and 21 - Blood will be drawn for safety tests and to measure blood levels of HIV and HCV HCV medications will be injected on days 7 and 21
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 pegylated interferon and ribavirin treatment and its effect on the HCV infection Eye examinations will be done every 3 months
Week 48 or end of treatment - Treatment with pegylated interferon and ribavirin will stop after 48 weeks At this time or earlier for those who do not complete the 48 weeks of treatment patients will return to the clinic for a routine visit blood tests including a test for hepatitis B and abdominal ultrasound Patients may also be hospitalized for 2 days for a repeat optional liver biopsy
Week 72 and extended follow-up visits - At week 72 patients will return for blood tests and a routine clinic visit HCV viral load will be measured Follow-up visits every 3 months for an additional year will include a blood test to measure HCV viral load and a complete physical examination
HIV-infected patients 18 years of age and older with chronic hepatitis C infection may be eligible for this study Patients must have an HCV viral load greater than 2000 copiesmL and a CD4 count that is either more than 500 cellsmm3 or more than 350 cellsmm3 with an HIV viral load no greater than 40000 particlesmL Candidates will be screened for current or previous diseases conditions or treatments that may exclude them from this study Screening includes a medical history and physical examination eye examination blood and urine tests chest X-ray electrocardiogram EKG liver ultrasound and possibly a liver biopsy if a recent one is not available The liver biopsy is optional and is done to determine the severity of liver disease Patients will be sedated for this test 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 Patients remain in the hospital overnight for monitoring Women of childbearing age will have a pregnancy test
Patients enrolled in the study will be randomly assigned to one of the following treatment groups 1 pegylated interferon and ribavirin for 48 weeks control group or 2 HAART for 6 months followed by 48 weeks of pegylated interferon and ribavirin
HAART group - Patients taking HAART will be followed in the clinic every 2 weeks for the first month and then monthly for the next 5 months After 6 months of HAART they will begin taking pegylated interferon and ribavirin and will follow the dosing and follow-up schedule outlined below for patients in the control group
Control group - Patients will have weekly injections under the skin of peginterferon alpha-2b and ribavirin pills daily by mouth Clinic visits will be scheduled as follows
Days 1 3 7 and 21 - Blood will be drawn for safety tests and to measure blood levels of HIV and HCV HCV medications will be injected on days 7 and 21
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 pegylated interferon and ribavirin treatment and its effect on the HCV infection Eye examinations will be done every 3 months
Week 48 or end of treatment - Treatment with pegylated interferon and ribavirin will stop after 48 weeks At this time or earlier for those who do not complete the 48 weeks of treatment patients will return to the clinic for a routine visit blood tests including a test for hepatitis B and abdominal ultrasound Patients may also be hospitalized for 2 days for a repeat optional liver biopsy
Week 72 and extended follow-up visits - At week 72 patients will return for blood tests and a routine clinic visit HCV viral load will be measured Follow-up visits every 3 months for an additional year will include a blood test to measure HCV viral load and a complete physical examination
Detailed Description:
Coinfection with the human immunodeficiency virus HIV and the hepatitis C virus HCV has risen dramatically since the explosion of the HIV pandemic twenty years ago with one third of all HIV positive persons also infected with HCV Numerous studies have suggested that HIV exacerbates several steps in the natural history of hepatitis C and as survival among HIV-infected patients increases hepatitis C-related morbidity and mortality is expected to follow a similar trend in coinfected patients Some investigators advocate the initiation of highly active antiretroviral therapy HAART for this population prior to the initiation of HCV therapy It is postulated that HAART will improve the host immune function by increasing the CD4 cell count and decreasing HIV viral load thought to be advantageous for patients starting HCV therapy Despite its promising hypothesis whether HAART ultimately leads to a reduction in HCV load in coinfected persons remains controversial This is a non-blinded randomized controlled trial to evaluate the impact of HAART on the immunologic virologic and clinical responses to HCV treatment with peginterferon and ribavirin in coinfected individuals with CD4 greater than or equal to 500 cellsmm 3 or greater than or equal to 350 cellsmm3 and a viral load less than or equal to 40000 copiesmL The study will also address the safety and efficacy of administering a combination of HAART along with peginterferon alpha-2b and ribavirin to HIV-infected individuals 128 patients who are coinfected with HIV and HCV will be recruited for the study and randomized to receive one of two treatment regimens 1 control group will be treated with peginterferon alpha-2b and ribavirin for 48 weeks or 2 experimental group will be treated with highly active antiretroviral therapy for six months At that point they will begin receiving peginterferon alpha-2b and ribavirin at the same doses as the control group for 48 weeks During the 72-week follow up period these patients will be monitored for both HCV and HIV viral loads and CD4 lymphocyte counts The results of the study will enable us to better delineate the relationship between the immune reconstitution effects induced by HAART and the clinical immunologic and virologic responses of coinfected persons treated with peginterferon and ribavirin In addition evaluating the safety of coadministering peginterferon ribavirin and HAART will further refine the best therapeutic regimen for this patient population
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 |
|---|---|---|---|
| 02-I-0139 | None | None | None |