text:
- 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.
This is an observational study. The observed treatment is received and managed through their primary care.
|Study Type:
|Study Design:
|Observational Model: Cohort
Time Perspective: Prospective
|Official Title:
|Study to Evaluate the Genetic, Epigenetic, and Proteomic Expression in Latino Participants With and Without HIV Coinfection Receiving Treatment for Hepatitis C
|Study Start Date:
|July 2010
|Study Completion Date:
|March 2013
|Primary Completion Date:
|March 2013 (Final data collection date for primary outcome measure)
Hepatitis C
latino participants with Hepatitis C
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:
|18 Years and older (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
|Sampling Method:
|Non-Probability Sample
A subject must satisfy all of the following criteria to be eligible to participate in this study:
A subject will be ineligible to participate in this study if any of the following criteria are met:
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01182298
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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)
|Responsible Party:
|National Institute of Allergy and Infectious Diseases (NIAID)
|ClinicalTrials.gov Identifier:
|NCT01182298 History of Changes
|Other Study ID Numbers:
10-I-0159 ( Registry Identifier: CLINICAL TRIALS )
|First Submitted:
|August 13, 2010
|First Posted:
|August 16, 2010
|Results First Submitted:
|April 23, 2014
|Results First Posted:
|October 2, 2014
|Last Update Posted:
|October 2, 2014
|Last Verified:
|September 2014
Viral Kinetics
IL-28 Haplotype
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections