Study on Immunopathogenesis in HIV and Hepatitis C Coinfection
|ClinicalTrials.gov Identifier: NCT01296529|
Recruitment Status : Completed
First Posted : February 15, 2011
Last Update Posted : December 12, 2012
Liver-related death is the leading cause of mortality in HIV-infected individuals with CD4+ cell counts over 200, and hepatitis C virus (HCV) infection is the greatest risk for liver-related mortality in HIV-positive patients. Compared to HCV monoinfected individuals, patients with HIV and HCV coinfection experience accelerated progression of liver fibrosis, which can lead to higher incidence of cirrhosis, end stage liver disease (ESLD), and death. Changes in CD8+ T-cell activation, inflammatory cytokines, and serum markers of tissue injury may offer an immunologic platform to determine factors associated with progressive liver fibrosis in coinfected patients. In this cross-sectional study we will evaluate whether HIV and HCV coinfection patients with well-controlled HIV infection who have an undetectable viral load exhibit abnormal levels of inflammation and immune activation, potentially contributing to advanced liver fibrosis. Comparative groups include coinfected patients successfully treated for hepatitis C, or who have absence of hepatitis C viremia through spontaneous clearance, hepatitis C monoinfected patients, and HIV-positive patients with well-controlled HIV infection without hepatitis C. Liver fibrosis will be measured by non-invasive methods.
The primary objectives of this study are:
- To determine if there are differences in markers of inflammation and immune activation in subsets of patients with HIV, hepatitis C, and HIV and hepatitis C coinfection.
- To assess the stage of liver fibrosis using non-invasive methods in subsets of patients with hepatitis C and HIV and hepatitis C coinfection and compare the degree of liver fibrosis with levels of inflammation and immune activation.
|Condition or disease|
|HIV Infection Hepatitis C Infection Fibrosis Inflammation|
|Study Type :||Observational|
|Actual Enrollment :||59 participants|
|Official Title:||A Pilot Study on Immunopathogenesis in HIV and Hepatitis C Coinfection|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||July 2012|
Evidence should include a copy of a laboratory report of testing positive for HIV antibodies and/or HIV viral RNA, and a negative antibody test for HCV
Evidence should include a copy of a laboratory report of testing positive for HCV antibodies and HCV viral RNA, and a negative antibody test for HIV
HIV and HCV coinfection
Evidence should include a copy of a laboratory report of testing positive for HIV or HIV viral RNA, and positive tests for HCV antibodies and HCV RNA.
HIV/HCV coinfection with HCV clearance
Evidence should include a copy of a laboratory report of testing positive for HIV or HIV viral RNA, a positive tests for HCV antibodies, and undetectable HCV RNA without hepatitis C treatment (spontaneous clearance) or >6 months after hepatitis therapy (sustained virologic response)
- Comparison of liver fibrosis with levels of inflammation and immune activation in subsets of patients with HIV, hepatitis C, and HIV and hepatitis C coinfection [ Time Frame: 6 months ]Assess the associations between liver fibrosis as the dependent variable measured as a fibrosis score in kPa with predictor variables (markers of inflammation [IL-1β, IL-6, IL-8, IL10, IL-12, IL-15, IL-17, IL-21, IP10, IFN-γ, TNF-α, macrophage inflammatory protein 1 alpha (CCR7), hsCRP], immune activation and senescence [CD3, CD4, CD8, HLA DR, CD38, Ki67 CD45RA, CCR7, CD28, CD57], and tissue injury [tissue factor]) for groups b, c, and d separately by using linear regression models. Group a is the control arm for the dependent variable.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01296529
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|Ruth M. Rothstein CORE Center|
|Chicago, Illinois, United States, 60612|
|Principal Investigator:||Gregory Huhn, MD, MPHTM||The Ruth M. Rothstein CORE Center|