Open Label Study to Evaluate Chronic Hepatitis C Treatment in Latino Subjects With and Without HIV Co-infection
Stopped early
Conditions studied: Hepatitis C, HIV
In brief
* 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. Objectives: \- 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.
Key facts
- Study ID
- NCT01182298
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 10
- Starts
- 2010-07-01
- Expected to finish
- 2013-03-01
- Last updated by the study team
- 2019-09-24
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- A subject will be ineligible to participate in this study if any of the following criteria are met:
- Unable to comply with research study visits
- Have any condition that the investigator considers a contraindication to study participation.
- Pregnant or breastfeeding women.
- Patients with poor venous access
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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