An Open Label Non-Randomized Dose Escalating Trial to Assess Safety and Tolerability of Alb-Interferon Alfa 2b Every Two Weeks With Ribavirin Among HIV/HCV Coinfected Individuals
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 1,000 mg or 1,200 mg by mouth twice daily, depending on a patient's 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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label Non-Randomized Trial to Assess Safety and Tolerability of Alb-Interferon Alfa 2b Every Two Weeks With Ribavirin Among HIV/HCV Coinfected Individuals|
- Safety and tolerability of two doses of Albinterferon alpha 2b with ribavirin.
- Histologic, virologic responses to Albinterferon alpha 2b and ribavirin
|Study Start Date:||June 2007|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
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 HIV/HCV 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 HIV/HCV 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 HIV/HCV coinfected subjects. This will be important given the current low cure rate of HCV among HIV coinfected individuals.
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|