Associations, Outcomes and Genomics of GB Virus C, Hepatitis C Virus and Human Immunodeficiency Virus Infection
1 other identifier
observational
158
1 country
1
Brief Summary
The purpose of this study is to examine the effect of GB virus C (GBV-C) on the natural history of chronic hepatitis C virus (HCV) infection in subjects co-infected with HIV and HCV. The other aspect of the study is to assess the effect of GBV-C on the severity of liver disease due to chronic hepatitis C in subjects co-infected with HIV and HCV. This will be done by determining the point prevalence of co-infection retrospectively then following that cohort prospectively. In addition, further individuals will be recruited in a prospective manner.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2004
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 14, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedDecember 5, 2013
September 1, 2005
3.2 years
September 13, 2005
December 3, 2013
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- Sera available and appropriate for testing, including serial sera over a period of time (retrospective analysis)
- HIV serology positive.
- Unequivocal HCV antibody positive or HCV RNA positive.
You may not qualify if:
- Those without sera available.
- Those unwilling to give informed consent.
- Persons with hepatitis B virus infection, as defined by the presence of hepatitis B surface antigen and/or hepatitis B virus DNA positive.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayside Healthlead
Study Sites (1)
Alfred Hospital
Melbourne, Victoria, 3181, Australia
Related Publications (2)
Berzsenyi MD, Bowden DS, Roberts SK. GB virus C: insights into co-infection. J Clin Virol. 2005 Aug;33(4):257-66. doi: 10.1016/j.jcv.2005.04.002.
PMID: 15922655RESULTBerzsenyi MD, Bowden DS, Kelly HA, Watson KM, Mijch AM, Hammond RA, Crowe SM, Roberts SK. Reduction in hepatitis C-related liver disease associated with GB virus C in human immunodeficiency virus coinfection. Gastroenterology. 2007 Dec;133(6):1821-30. doi: 10.1053/j.gastro.2007.08.076. Epub 2007 Sep 5.
PMID: 18054555DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark D Berzsenyi, MBBS
Alfred Hospital/Bayside Health
- STUDY DIRECTOR
Stuart R Roberts, MBBS
Alfred Hospital/Bayside Health
Study Design
- Study Type
- observational
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 14, 2005
Study Start
February 1, 2004
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
December 5, 2013
Record last verified: 2005-09