The Natural History and Treatment of Acute Hepatitis C Virus (HCV) in HIV-positive Individuals (PROBE-C)
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.
Acute Hepatitis C
|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|
- SVR [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
For phylogenetic analysis HCV RNA detection will be performed.
|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)|
|HCV + HIV|
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:
- 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
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01289652
|Contact: Juergen K Rockstroh, MDfirstname.lastname@example.org|
|Contact: Christoph Boesecke, MDemail@example.com|
|Bonn University Hospital||Recruiting|
|Bonn, NSW, Germany, 53129|
|Contact: Christoph Boesecke, MD firstname.lastname@example.org|
|Principal Investigator: Juergen K Rockstroh, MD|