HIV Infections Clinical Trial
Official title:
Cellular Immune Responses to Hepatitis B Virus (HBV)- Longitudinal Follow up and Natural History
Verified date | January 2012 |
Source | The Alfred |
Contact | n/a |
Is FDA regulated | No |
Health authority | Australia: National Health and Medical Research Council |
Study type | Observational |
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
Status | Completed |
Enrollment | 104 |
Est. completion date | December 2009 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Australia | The Alfred Hospital, Commercial Road | Melbourne | Victoria |
Lead Sponsor | Collaborator |
---|---|
The Alfred | National Institutes of Health (NIH) |
Australia,
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