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

NCT01289652 | Unknown DMC

• 2 other identifiers: PROBE-C V 2.3, 03 June 20NEAT
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Hepatitis C; HIV

Keywords

Acute hepatitis C (HCV); Human immunodeficiency virus (HIV)

Outcome Measures

Primary Outcomes (1)

• SVR

  3 years

Study Arms (2)

HCV + HIV

HCV

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

600 acute HCV infections with/without HIV infection

You may qualify if:

• 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

You may not qualify if:

• Acute liver disease other than hepatitis C
• Inability to provide written informed consent
• Younger than 18 years of age

Sponsors & Collaborators

• Benedetta Mattioli: lead

Study Sites (1)

Bonn University Hospital

Bonn, NSW, 53129, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

For phylogenetic analysis HCV RNA detection will be performed.

MeSH Terms

Conditions

Hepatitis C; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; HIV Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Central Study Contacts

Juergen K Rockstroh, MD

CONTACT

juergen.rockstroh@ukb.uni-bonn.de

Christoph Boesecke, MD

CONTACT

christoph.boesecke@ukb.uni-bonn.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 3, 2011
• First Posted: February 4, 2011
• Study Start: May 1, 2011
• Primary Completion: May 1, 2016
• Study Completion: April 1, 2017
• Last Updated: April 23, 2014

Record last verified: 2014-04

Locations

DE (1)