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

This study has been completed.
Sponsor:
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
History of Changes
  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:

  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
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:

U.S. FDA Resources

Further study details as provided by The Alfred:

Biospecimen Retention:   Samples Without DNA
plasma

Enrollment: 104
Study Start Date: December 2004
Study Completion Date: December 2009
  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by 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 September 30, 2016