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NCT01296529 · ClinicalTrials.gov registry record

Study on Immunopathogenesis in HIV and Hepatitis C Coinfection

A clinical trial of Inflammation and HIV Infection, sponsored by Rush University Medical Center.

Completed
Registry status
59
Enrollment target
2
Study locations

NCT01296529 is a study of Inflammation and HIV Infection that has completed, run by Rush University Medical Center. The registered enrollment target is 59 participants, below the 288-participant average among 132 other Inflammation trials with a reported enrollment target (80% lower). The trial reports 2 study locations across 1 state.

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The verdict

NCT01296529, a study of Inflammation and HIV Infection, has completed, sponsored by Rush University Medical Center.

COMPLETED
Registry status
59 participants
Enrollment target
2
Study locations

Study Summary

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: 1. 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. 2. 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.

Study Locations (2)

Illinois

  • Rush University Medical Center - Chicago
  • Ruth M. Rothstein CORE Center - Chicago

Trial Details

FieldValue
Enrollment Target 59 participants
Start Date 2011-07
Est. Completion 2012-07

Sponsor

Rush University Medical Center

320 total trials

What the Registry Record Tells You About NCT01296529

The ClinicalTrials.gov registry entry for NCT01296529 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 288-participant average among 132 other Inflammation trials with a reported enrollment target (80% lower). The listed sponsor is Rush University Medical Center, which has 320 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Inflammation appearing as the primary indexed condition, and to 0 interventions.

NCT01296529 reports 2 study locations spanning 1 distinct geographic area - top geographies include Illinois.

Frequently Asked Questions

What is clinical trial NCT01296529 about?

NCT01296529 is a clinical study titled "Study on Immunopathogenesis in HIV and Hepatitis C Coinfection". 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 coinf...

What is the current status of trial NCT01296529?

This trial is currently completed. The enrollment target is 59 participants. The study started on 2011-07. Estimated completion is 2012-07.

What conditions does trial NCT01296529 study?

This clinical trial studies the following conditions: Inflammation, HIV Infection, Fibrosis, Hepatitis C Infection.

Who is sponsoring clinical trial NCT01296529?

This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01296529 being conducted?

This trial has 2 study locations across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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