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
  Purpose

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.


Condition
Acute Hepatitis C
HIV

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: PRospective OBservational Evaluation of the Natural History and Treatment of Acute HCV in HIV-positive Individuals: The PROBE-C Study

Resource links provided by NLM:


Further study details as provided by Istituto Superiore di Sanità:

Primary Outcome Measures:
  • SVR [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

For phylogenetic analysis HCV RNA detection will be performed.


Estimated Enrollment: 600
Study Start Date: May 2011
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
HCV + HIV
HCV

Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

600 acute HCV infections with/without HIV infection

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01289652

Contacts
Contact: Juergen K Rockstroh, MD juergen.rockstroh@ukb.uni-bonn.de
Contact: Christoph Boesecke, MD christoph.boesecke@ukb.uni-bonn.de

Locations
Germany
Bonn University Hospital Recruiting
Bonn, NSW, Germany, 53129
Contact: Christoph Boesecke, MD       christoph.boesecke@ukb.uni-bonn.de   
Principal Investigator: Juergen K Rockstroh, MD         
Sponsors and Collaborators
Benedetta Mattioli
  More Information

Additional Information:
No publications provided

Responsible Party: Benedetta Mattioli, MD, Istituto Superiore di Sanità
ClinicalTrials.gov Identifier: NCT01289652     History of Changes
Other Study ID Numbers: PROBE-C V 2.3, 03 June 20, NEAT
Study First Received: February 3, 2011
Last Updated: April 22, 2014
Health Authority: Federal Institute for Drugs and Medicinal Devices Germany:

Keywords provided by Istituto Superiore di Sanità:
Acute hepatitis C (HCV)
Human immunodeficiency virus (HIV)

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
HIV Seropositivity
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Liver Diseases
Picornaviridae Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Virus Diseases

ClinicalTrials.gov processed this record on October 20, 2014