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

NCT ID: NCT00168194

Last Updated: 2012-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-12-31

Study Completion Date

2009-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Hepatitis B HIV Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.


* 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


* To be HIV/HBV co-infected

All patients:

* To be over 18 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

The Alfred

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Hoy

Professor Jennifer Hoy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sharon Lewin, Professor

Role: PRINCIPAL_INVESTIGATOR

Burnet Institute, Melbourne

Locations

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The Alfred Hospital, Commercial Road

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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235/04

Identifier Type: -

Identifier Source: org_study_id

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