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

The Alfred

Status: Completed

Conditions: Hepatitis B; HIV Infections

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00168194

235/04

Details and patient eligibility

About

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

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.