Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000553673
Ethics application status
Approved
Date submitted
16/09/2005
Date registered
29/09/2005
Date last updated
13/11/2019
Date data sharing statement initially provided
13/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cellular Immune responses to Hepatitis B Virus (HBV)- Longitudinal follow up and Natural History
Scientific title
Cellular Immune responses to Hepatitis B Virus (HBV)- Longitudinal follow up and Natural History
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis B infection and Hepatitis B/HIV co-infection 678 0
Condition category
Condition code
Infection 752 752 0 0
Acquired immune deficiency syndrome (AIDS / HIV)
Inflammatory and Immune System 753 753 0 0
Liver

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
None, this is an observational study

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 patients 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.
Intervention code [1] 640 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 939 0
To characterize HBV-specific T cell responses in HBV chronic carriers
Timepoint [1] 939 0
Primary outcome [2] 940 0
To identify novel immunogenic regions in both HLA-A2+ and non-HLA-A2+ individuals
Timepoint [2] 940 0
Primary outcome [3] 941 0
To determine the effect of HIV infection on HBV-specific T-cell responses
Timepoint [3] 941 0
Secondary outcome [1] 1797 0
Timepoint [1] 1797 0

Eligibility
Key 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)1- Acute hepatitis B2- Chronic hepatitis B, HBV DNA+ve , normal ALT , HBeAg +ve3- Chronic hepatitis B, HBV DNA +ve , normal ALT, HBeAg -ve4- Chronic hepatitis , HBV DNA +ve, increased ALT, no HBV treatment B, HBeAg +ve5- Chronic hepatitis B, HBV DNA +ve , increased ALT, no HBV treatment B, HBeAg -ve6- Chronic hepatitis B, undergoing 'flare' of hepatitis. Group B inclusion criteria:to be HIV/HBV co-infected.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/01/2005
Actual
5/01/2005
Date of last participant enrolment
Anticipated
Actual
1/12/2007
Date of last data collection
Anticipated
Actual
1/02/2009
Sample size
Target
104
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 833 0
Government body
Name [1] 833 0
NIH
Country [1] 833 0
United States of America
Primary sponsor type
Government body
Name
NIH
Address
Country
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2096 0
The Alfred Hospital
Ethics committee address [1] 2096 0
Ethics committee country [1] 2096 0
Australia
Date submitted for ethics approval [1] 2096 0
Approval date [1] 2096 0
01/12/2004
Ethics approval number [1] 2096 0
Ethics committee name [2] 2097 0
The Royal Melbourne Hospital
Ethics committee address [2] 2097 0
Ethics committee country [2] 2097 0
Australia
Date submitted for ethics approval [2] 2097 0
Approval date [2] 2097 0
18/11/2002
Ethics approval number [2] 2097 0
Ethics committee name [3] 304732 0
HIVNAT
Ethics committee address [3] 304732 0
Ethics committee country [3] 304732 0
Thailand
Date submitted for ethics approval [3] 304732 0
Approval date [3] 304732 0
01/10/2007
Ethics approval number [3] 304732 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35808 0
Address 35808 0
Country 35808 0
Phone 35808 0
Fax 35808 0
Email 35808 0
Contact person for public queries
Name 9829 0
Professor Sharon Lewin
Address 9829 0
Infectious Diseases Department
Alfred Hospital
2nd floor
Burnet Institute
Commercial Rd
Melbourne VIC 3004
Country 9829 0
Australia
Phone 9829 0
+61 3 92763009
Fax 9829 0
+61 3 92762431
Email 9829 0
[email protected]
Contact person for scientific queries
Name 757 0
Professor Sharon Lewin
Address 757 0
Infectious Diseases Department
Alfred Hospital
2nd floor
Burnet Institute
Commercial Rd
Melbourne VIC 3004
Country 757 0
Australia
Phone 757 0
+61 3 92763009
Fax 757 0
+61 3 92762431
Email 757 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.