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

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ClinicalTrials.gov Identifier: NCT01289652
Recruitment Status : Unknown
Verified April 2014 by Benedetta Mattioli, Istituto Superiore di Sanità.
Recruitment status was:  Recruiting
First Posted : February 4, 2011
Last Update Posted : April 23, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Acute Hepatitis C HIV

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.

Study Design

Study Type : Observational
Estimated Enrollment : 600 participants
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
Study Start Date : May 2011
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
HCV + HIV
HCV


Outcome Measures

Primary Outcome Measures :
  1. SVR [ Time Frame: 3 years ]

Biospecimen Retention:   Samples With DNA
For phylogenetic analysis HCV RNA detection will be performed.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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 ( Other Grant/Funding Number: NEAT002 )
First Posted: February 4, 2011    Key Record Dates
Last Update Posted: April 23, 2014
Last Verified: April 2014

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

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections