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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00168194
Enrollment
104
Registered
2005-09-15
Start date
2004-12-31
Completion date
2009-12-31
Last updated
2012-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B, HIV Infections

Keywords

HIV

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

Interventions

None listed

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
The Alfred
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026