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

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

This study is currently recruiting participants.
Verified by The Alfred, May 2008

Sponsors and Collaborators:	The Alfred National Institutes of Health (NIH)
Information provided by:	The Alfred
ClinicalTrials.gov Identifier:	NCT00168194

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

MedlinePlus related topics:

AIDS Hepatitis Hepatitis B

ChemIDplus related topics:

Hepatitis B Vaccines

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

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

Further study details as provided by The Alfred:

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

plasma

Estimated Enrollment:	104
Study Start Date:	December 2004
Estimated Study Completion Date:	December 2009

Eligibility

Ages Eligible for Study:	18 Years and older
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00168194

Contacts


Contact: Sharon Lewin, Prof	0061 3 9276 3009	S.Lewin@alfred.org.au

Locations


Australia, Victoria
	The Alfred Hospital, Commercial Road	Recruiting
	Melbourne, Victoria, Australia, 3004
	Contact: Sharon Lewin, Professor 0061 3 9276 3009 S.Lewin@alfred.org.au

Sponsors and Collaborators

The Alfred

National Institutes of Health (NIH)

Investigators


Principal Investigator:	Sharon Lewin, Professor	Burnet Institute, Melbourne

More Information

Responsible Party:	The Alfred Hospital ( Professor Sharon Lewin )
Study ID Numbers:	235/04
First Received:	September 9, 2005
Last Updated:	May 16, 2008
ClinicalTrials.gov Identifier:	NCT00168194
Health Authority:	Australia: National Health and Medical Research Council

Keywords provided by The Alfred:

HIV

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral

Liver Diseases

Acquired Immunodeficiency Syndrome

Hepatitis, Viral, Human

Immunologic Deficiency Syndromes

Hepatitis

Virus Diseases

Digestive System Diseases

HIV Infections

Sexually Transmitted Diseases

Hepatitis B

DNA Virus Infections

Retroviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections

Slow Virus Diseases

Immune System Diseases

Lentivirus Infections

Infection

Hepadnaviridae Infections

ClinicalTrials.gov processed this record on September 22, 2008