Trial record 2 of 43 for:
" January 19, 2011":" February 18, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
The Natural History and Treatment of Acute Hepatitis C Virus (HCV) in HIV-positive Individuals (PROBE-C)
This study is not yet open for participant recruitment.
Verified June 2010 by Istituto Superiore di Sanita
Sponsor:
Istituto Superiore di Sanita
Information provided by:
Istituto Superiore di Sanita
ClinicalTrials.gov Identifier:
NCT01289652
First received: February 3, 2011
Last updated: NA
Last verified: June 2010
History: No changes posted
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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 Infections |
| 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 Sanita:
Biospecimen Retention: Samples With DNA
Detailed Description:
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 2014 (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:
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
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
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
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 |
Sponsors and Collaborators
Istituto Superiore di Sanita
More Information
Additional Information:
No publications provided
| Responsible Party: | Prof. Jürgen Rockstroh, University of Bonn, Germany |
| 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: | February 3, 2011 |
| Health Authority: | Federal Institute for Drugs and Medicinal Devices Germany: |
Keywords provided by Istituto Superiore di Sanita:
|
Acute hepatitis C (HCV) Human immunodeficiency virus (HIV) |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome HIV Seropositivity Hepatitis Hepatitis A Hepatitis C Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Enterovirus Infections Picornaviridae Infections Flaviviridae Infections |
ClinicalTrials.gov processed this record on June 18, 2013