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Associations, Outcomes and Genomics of GB Virus C, Hepatitis C Virus and Human Immunodeficiency Virus Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00164060
Recruitment Status : Terminated
First Posted : September 14, 2005
Last Update Posted : December 5, 2013
Sponsor:
Information provided by:

Study Description
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.

Condition or disease
Hepatitis C HIV Infections

  Show Detailed Description

Study Design

Study Type : Observational
Actual Enrollment : 158 participants
Time Perspective: Retrospective
Official Title: Associations, Outcomes and Genomics of GB Virus C, Hepatitis C Virus and Human Immunodeficiency Virus Infection
Study Start Date : February 2004
Primary Completion Date : May 2007
Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Sera available and appropriate for testing, including serial sera over a period of time (retrospective analysis)
  2. HIV serology positive.
  3. Unequivocal HCV antibody positive or HCV RNA positive.

Exclusion Criteria:

  1. Those without sera available.
  2. Those unwilling to give informed consent.
  3. Persons with hepatitis B virus infection, as defined by the presence of hepatitis B surface antigen and/or hepatitis B virus DNA positive.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00164060


Locations
Australia, Victoria
Alfred Hospital
Melbourne, Victoria, Australia, 3181
Sponsors and Collaborators
Bayside Health
Investigators
Principal Investigator: Mark D Berzsenyi, MBBS Alfred Hospital/Bayside Health
Study Director: Stuart R Roberts, MBBS Alfred Hospital/Bayside Health
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00164060     History of Changes
Other Study ID Numbers: 35/04
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: December 5, 2013
Last Verified: September 2005

Keywords provided by Bayside Health:
HCV
HIV co-infection

Additional relevant MeSH terms:
Infection
Communicable Diseases
Hepatitis
Hepatitis A
Hepatitis C
HIV Infections
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases