Peginterferon Alpha-2a and Ribavirin to Treat Hepatitis C in HIV-infected Patients (PIFNPK)
This study will evaluate the safety and effectiveness of combination therapy with peginterferon alpha-2a and ribavirin for treating hepatitis C virus (HCV) infection in HIV-infected patients. Peginterferon alpha with ribavirin is the therapy of choice for people with HCV alone. Peginterferon alpha-2a is a compound that results from attaching a polyethylene glycol molecule to interferon alpha-2a. This compound stays in the blood longer than unmodified interferon alpha-2a, causing a higher blood concentration and thus maintaining greater activity against the hepatitis C virus.
HIV-infected patients 18 years of age and older with chronic hepatitis C infection and a viral load greater than 2000 copies/mL may be eligible for this 2-1/2 year study. Candidates are screened with a medical history and physical examination, blood and urine tests, eye examination, chest x-ray, electrocardiogram (EKG), liver ultrasound, and pregnancy test in women who are able to become pregnant. If a recent liver biopsy is not available, this test is done to determine the type and severity of liver disease. The patient is given a sedative before the procedure. Then, 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.
Participants begin treatment with injections under the skin of peginterferon alpha-2a and ribavirin pills by mouth on study day 0. Peginterferon is given either once or twice a week for 4 weeks and then once a week for 44 weeks. Ribavirin is given daily. In addition, patients continue to take all other medications prescribed by their doctor. Clinic visits are scheduled for the following procedures:
- Days 1, 3, 4, 7, 10 and weeks 2, 3, and 4 - Blood tests for safety measures and to measure blood levels of HIV and HCV.
- Weeks 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 - Blood and urine tests to determine the side effects of treatment and its effect on the HCV infection. In addition, eye examinations are done every 3 months, and pregnancy and thyroid function tests are done several times during the treatment period.
- Week 48 or end of treatment - Treatment stops after 48 weeks. At this time, or earlier for those who do not complete the 48 weeks, patients return to the clinic for a chest x-ray, EKG, blood tests, and abdominal ultrasound. Patients are hospitalized for a repeat liver biopsy.
- Weeks 52, 56, 64 and 72 - Blood and urine tests to determine the side effects of treatment and its effect on the HCV infection, and a urine pregnancy test in women.
|Hepatitis C HIV Infections||Drug: Double dose pegylated interferon with weight based Ribavirin Drug: standard dose pegylated interferon alfa -2a and ribavirin||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Twice-Weekly Peginterferon Alpha 2a and Ribavirin Induction Therapy for Chronic Hepatitis C in Patients Who Are Coinfected With HIV-1|
- Number of Participants With Sustained Virologic Response (SVR) [ Time Frame: 72 weeks ]SVR [ Sustained virological response] SVR was defined as HCV RNA levels below the limit of detection 24 weeks after the end of treatment.
- Number of Participants With Normalization of Liver Enzymes [ Time Frame: week 24, week 48, week 72 ]normalization of liver enzymes :Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) Alanine aminotransferase (ALT): Normal 6 - 41 U/L Aspartate aminotransferase (AST) : Normal 9 - 34 U/L
- Number of Participants With Adverse Events [ Time Frame: 48 weeks ]
- Anemia, Neutropenia and Psychiatric adverse events
|Study Start Date:||June 2004|
|Study Completion Date:||November 2008|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
Active Comparator: Standard dose arm
Pegylated interferon alfa -2a STANDARD DOSE Pegasys 180ug/week
Drug: standard dose pegylated interferon alfa -2a and ribavirin
pegylated interferon alfa -2a 180ug weekly and weight based ribavirin for duration of the treatment
Other Name: pegasys
Experimental: Double dose arm
Double dose pegylated interferon with weight based Ribavirin
Drug: Double dose pegylated interferon with weight based Ribavirin
pegylated interferon alfa -2a 180ug/twice weekly and weight based ribavirin for 4 weeks then pegylated interferon alfa -2a 180ug/ weekly for the remainder of the treatment
Other Name: Pegasys
Please refer to this study by its ClinicalTrials.gov identifier: NCT00085917
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Shyam Kottilil||National Institute of Allergy and Infectious Diseases (NIAID)|