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Cellular Immune Responses to Hepatitis B Virus (HBV)- Longitudinal Follow up and Natural History
This study has been completed.
Sponsor:
The Alfred
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Jennifer Hoy, The Alfred
ClinicalTrials.gov Identifier:
NCT00168194
First received: September 9, 2005
Last updated: January 19, 2012
Last verified: January 2012
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Purpose
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:
- 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.
- To determine the effect of HIV infection on HBV-specific T-cell responses
| Condition |
|---|
| Hepatitis B HIV Infections |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Cellular Immune Responses to Hepatitis B Virus (HBV)- Longitudinal Follow up and Natural History |
Resource links provided by NLM:
Further study details as provided by Jennifer Hoy, The Alfred:
Eligibility| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00168194
Please refer to this study by its ClinicalTrials.gov identifier: 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
| Responsible Party: | Jennifer Hoy, Professor Jennifer Hoy, The Alfred |
| ClinicalTrials.gov Identifier: | NCT00168194 History of Changes |
| Other Study ID Numbers: |
235/04 |
| Study First Received: | September 9, 2005 |
| Last Updated: | January 19, 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 |
ClinicalTrials.gov processed this record on June 23, 2017