NCT00164060

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

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2004

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

December 5, 2013

Status Verified

September 1, 2005

Enrollment Period

3.2 years

First QC Date

September 13, 2005

Last Update Submit

December 3, 2013

Conditions

Keywords

HCVHIV co-infection

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Alfred Hospital

Melbourne, Victoria, 3181, Australia

Location

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.

  • Berzsenyi 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.

MeSH Terms

Conditions

Hepatitis CHIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Mark D Berzsenyi, MBBS

    Alfred Hospital/Bayside Health

    PRINCIPAL INVESTIGATOR
  • Stuart R Roberts, MBBS

    Alfred Hospital/Bayside Health

    STUDY DIRECTOR

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

Locations