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

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

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Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Genital Diseases HIV Infections Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Liver Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Alfred Hospital, Commercial Road

Melbourne, Victoria, 3004, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Sponsors and collaborators

Lead sponsor

The Alfred

Other

Collaborators

National Institutes of Health (NIH)

Registry information

Important dates

Study start: 2004
Study completion: 2009
First posted: Sep 15, 2005
Registry last updated: Jan 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed