The Natural History and Treatment of Acute Hepatitis C Virus (HCV) in HIV-positive Individuals (PROBE-C)
|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
|Condition or disease|
|Acute Hepatitis C 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.
|Study Type :||Observational|
|Estimated Enrollment :||600 participants|
|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|
|HCV + HIV|
- SVR [ Time Frame: 3 years ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|