Open Label Study to Evaluate the Safety, Efficacy, Viral Kinetics, Genetic, Epigenetic, and Proteomic Expression of Weekly Peginterferon Alpha 2a and Ribavirin Therapy for Chronic Hepatitis C in Latino Subjects With and Without HIV Co-infection
- Peginterferon alfa-2a has been approved by the U.S. Food and Drug Administration (FDA) to treat adults with chronic hepatitis C virus (HCV) infection with liver disease who have not been previously treated with interferon-alpha drugs (which improve immune system response to infection). Ribavirin has been approved by the FDA and is usually given in combination with interferon drugs such as peginterferon alfa-2a for treatment of chronic HCV.
- Recent research shows that Latino whites do not respond as well to treatment with peginterferon alfa-2a and ribavirin as non-Latino whites. Various factors such as excessive weight, gender, and insulin resistance were evaluated to explain this difference, but research suggests that underlying factors related to Latino or non-Latino background, possibly genetic and immune differences, may be affecting the response to HCV infection and treatment. However, more research is needed on the effectiveness of peginterferon and ribavirin in Latino subjects with HCV, and with combined and human immunodeficiency virus (HIV) co-infection.
- To evaluate the safety, effectiveness, and viral response of peginterferon alfa-2a and ribavirin therapy for chronic hepatitis C in Latino participants with and without HIV co-infection.
- Latino individuals at least 18 years of age who have been diagnosed with hepatitis C. (Both parents and all grandparents of the participant must be Latino, with Spanish as the primary language. Participants must be white; native aboriginal Indians, Asians, and blacks will be excluded.)
- Individuals who are co-infected with the human immunodeficiency virus (HIV) are also eligible for the study.
- Participants will be screened with a complete medical history, blood and urine samples, imaging studies (e.g., abdominal ultrasound, chest x-ray) and an eye exam. Participants who have not had a liver biopsy within the past year will have one as part of the screening for the study.
- Participants will receive ribavirin twice a day and an injection of peginterferon alfa-2a once a week. Participants or someone close to them will be shown how to give the injections.
- Participants will have regular blood and urine tests to evaluate HIV and HCV viral loads and interferon levels.
- At week 16, participants whose viral loads have not responded to therapy will stop treatment. At week 24, participants who still have detectable virus levels will stop treatment. Participants who show improvement will end treatment at week 48. All participants will have blood tests and imaging studies at the end of their treatment.
- Participants will have a follow-up visit 6 months after the end of treatment for final blood tests and imaging studies.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Study to Evaluate the Genetic, Epigenetic, and Proteomic Expression in Latino Participants With and Without HIV Coinfection Receiving Treatment for Hepatitis C|
- The primary end point of this study is the log change in HCV RNA levels on Day 7 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Safety, efficacy, viral kinetics, immunological responses, genetic, epigenetic, and proteomic expression of weekly peginterferon alpha-2a and daily ribavirin therapy for chronic hepatitis C in Latino subjects with and without HIV co-infection. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||July 2010|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Drug: Pegylated interferon with ribavirin
Hepatitis C is a major health problem affecting 100- 300 million individuals worldwide. Chronic hepatitis C virus (HCV) infection leads to cirrhosis in approximately 20% of subjects over a period of 1-20 years. Hepatitis C is now the most common indication for liver transplantation in the United States. infection occurs in one-third of all HIV-infected individuals, and the natural history among HIV-1 infected individuals demonstrates higher levels of HCV viremia, faster rates of progression and cirrhosis. There have been very few studies addressing the lower therapeutic response rates in minorities outside of African Americans. A recent study showed that Latino white subjects respond less effectively (34%) than non Latino white subjects (49%) given the same treatment even after adjusting for various important factors. As the current landscape for treatment of HCV changes, it would be important to evaluate factors responsible for therapeutic response in Latino patients.
This is a study to address the genetic, epigenetic, and proteomic expression during therapy for chronic hepatitis C in Latino participants with and without HIV co-infection. One hundred Latino participants who have evidence of chronic hepatitis C with and without HIV who are receiving treatment for HCV will be enrolled. The results of this study will enable us to explore reasons for the differential therapeutic response rates with Hepatitis C treatment in Latino participants with and without HIV coinfection.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01182298
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Shyamasundaran Kottilil, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|