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

This study has been completed.
Sponsor:
Collaborator:
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

September 9, 2005
January 19, 2012
December 2004
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Complete list of historical versions of study NCT00168194 on ClinicalTrials.gov Archive Site
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Cellular Immune Responses to Hepatitis B Virus (HBV)- Longitudinal Follow up and Natural History
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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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:

plasma

Non-Probability Sample

HIV and hepatitis B co-infection

  • Hepatitis B
  • HIV Infections
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
104
December 2009
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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.

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00168194
235/04
No
Jennifer Hoy, The Alfred
The Alfred
National Institutes of Health (NIH)
Principal Investigator: Sharon Lewin, Professor Burnet Institute, Melbourne
The Alfred
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP