The Natural History and Treatment of Acute Hepatitis C Virus (HCV) in HIV-positive Individuals (PROBE-C)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Istituto Superiore di Sanità
Sponsor:
Information provided by (Responsible Party):
Benedetta Mattioli, Istituto Superiore di Sanità
ClinicalTrials.gov Identifier:
NCT01289652
First received: February 3, 2011
Last updated: April 22, 2014
Last verified: April 2014

February 3, 2011
April 22, 2014
May 2011
May 2016   (final data collection date for primary outcome measure)
SVR [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01289652 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Natural History and Treatment of Acute Hepatitis C Virus (HCV) in HIV-positive Individuals
PRospective OBservational Evaluation of the Natural History and Treatment of Acute HCV in HIV-positive Individuals: The PROBE-C Study

The aim of the study is to investigate the epidemiology, natural history and treatment outcomes of acute hepatitis C (HCV) infection. Given the current pattern of case reporting, the cohort will be largely made up of human immunodeficiency virus (HIV)-positive patients, but HIV-negative patients with acute hepatitis C (AHC) will also be enrolled to enable comparisons to be made as appropriate and possible.

In a multi-center, prospective, open cohort study, patients with documented acute hepatitis C infection will be followed prospectively over an initial time-period of 3 years after diagnosis of acute hepatitis C infection to investigate:

  1. epidemiology

    • to describe the characteristics of patients who have acquired acute HCV infection, including examination of regional differences in modes of transmission, behavioural factors, concomitant sexually transmitted diseases, clinical presentation and associated laboratory test results.
    • characterization of the HCV strains circulating within the community using phylogenetic analysis
  2. natural history

    • determination of the rate of spontaneous viral clearance, and the clinical, immunological, host genetic and viral factors associated with viral clearance
    • progression of liver disease after acute hepatitis C; including the use of non-invasive liver fibrosis markers to estimate rates of liver fibrosis progression
  3. treatment strategies

    • describe the outcome of different treatment strategies for acute HCV infection, although it is acknowledged that there will be no random allocation of treatment strategies.
    • investigate factors associated with treatment response including time to initiation of therapy, duration of therapy, the use of ribavirin and genetic factors.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

For phylogenetic analysis HCV RNA detection will be performed.

Non-Probability Sample

600 acute HCV infections with/without HIV infection

  • Acute Hepatitis C
  • HIV
Not Provided
  • HCV + HIV
  • HCV
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
April 2017
May 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Documented current or past acute hepatitis C infection with detectable HCV-RNA (PCR-assay) with an estimated duration of 52 weeks at diagnosis as defined below:

    • First HCV RNA positive AND
    • Prior negative anti-HCV antibody or HCV RNA test within 12 months OR
    • Rise of liver transaminases above 2.5 x upper limit of normal (ULN) within the past 12 months with prior normal transaminases during the year before AND
    • Exclusion of other causes of acute hepatitis

Exclusion Criteria:

  • Acute liver disease other than hepatitis C
  • Inability to provide written informed consent
  • Younger than 18 years of age
Both
18 Years to 75 Years
No
Contact: Juergen K Rockstroh, MD juergen.rockstroh@ukb.uni-bonn.de
Contact: Christoph Boesecke, MD christoph.boesecke@ukb.uni-bonn.de
Germany
 
NCT01289652
PROBE-C V 2.3, 03 June 20, NEAT
Yes
Benedetta Mattioli, Istituto Superiore di Sanità
Benedetta Mattioli
Not Provided
Not Provided
Istituto Superiore di Sanità
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP