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Cellular Immune Responses to Hepatitis B Virus (HBV)- Longitudinal Follow up and Natural History

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ClinicalTrials.gov Identifier: NCT00168194
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : January 20, 2012
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Jennifer Hoy, The Alfred

Study Description
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Brief Summary:

It remains unclear why some individuals are able to clear HBV from their bodies while in others HBV is a persistent infection. We plan to investigate this process by collecting blood and analysing how the patient's white blood cells respond to different pieces of the HBV virus. We will use new tools that can precisely tell us which component of the immune response may be different in individuals who are chronically infected with HBV and also in individuals who are also infected with HIV.

The primary aims are therefore:

  1. To characterize HBV-specific T cell responses in HBV chronic carriers, and identify novel immunogenic regions in both HLA-A2+ and non-HLA-A2+ individuals.
  2. To determine the effect of HIV infection on HBV-specific T-cell responses

Condition or disease
Hepatitis B HIV Infections

Study Design
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Study Type : Observational
Actual Enrollment : 104 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cellular Immune Responses to Hepatitis B Virus (HBV)- Longitudinal Follow up and Natural History
Study Start Date : December 2004
Actual Study Completion Date : December 2009

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U.S. FDA Resources

Groups and Cohorts
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Outcome Measures
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Biospecimen Retention:   Samples Without DNA
plasma

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV and hepatitis B co-infection
Criteria

Inclusion Criteria:

There are two groups of patients in this study. Group A mono-infected with Hepatitis B, and those with co-infection HBV/HIV.

Group A inclusion criteria: (also split into 6 recruiting groups)

  • Acute hepatitis B
  • Chronic hepatitis B, HBV DNA+ve , normal ALT , HBeAg +ve
  • Chronic hepatitis B, HBV DNA +ve , normal ALT, HBeAg -ve
  • Chronic hepatitis , HBV DNA +ve, increased ALT, no HBV treatment B, HBeAg +ve
  • Chronic hepatitis B, HBV DNA +ve , increased ALT, no HBV treatment B, HBeAg -ve
  • Chronic hepatitis B, undergoing 'flare' of hepatitis

Group B inclusion criteria:

  • To be HIV/HBV co-infected

All patients:

  • To be over 18 years

Exclusion Criteria:

  • Those who do not fit the inclusion criteria.
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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): NCT00168194


Locations
Australia, Victoria
The Alfred Hospital, Commercial Road
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
The Alfred
National Institutes of Health (NIH)
Investigators
Principal Investigator: Sharon Lewin, Professor Burnet Institute, Melbourne
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Jennifer Hoy, Professor Jennifer Hoy, The Alfred
ClinicalTrials.gov Identifier: NCT00168194     History of Changes
Other Study ID Numbers: 235/04
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: January 20, 2012
Last Verified: January 2012

Keywords provided by Jennifer Hoy, The Alfred:
HIV

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
HIV Infections
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
 RNA Virus Infections
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Hepadnaviridae Infections
DNA Virus Infections