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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00168194




Registration number
NCT00168194
Ethics application status
Date submitted
9/09/2005
Date registered
15/09/2005
Date last updated
20/01/2012

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
Secondary ID [1] 0 0
235/04
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis B 0 0
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

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)

- 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Those who do not fit the inclusion criteria.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2009
Sample size
Target
Accrual to date
Final
104
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital, Commercial Road - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The Alfred
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Institutes of Health (NIH)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT00168194
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sharon Lewin, Professor
Address 0 0
Burnet Institute, Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00168194