NCT00168194

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. 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. 2.To determine the effect of HIV infection on HBV-specific T-cell responses

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

January 20, 2012

Status Verified

January 1, 2012

First QC Date

September 9, 2005

Last Update Submit

January 19, 2012

Conditions

Hepatitis BHIV Infections

Keywords

HIV

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HIV and hepatitis B co-infection

You may qualify if:

  • There are two groups of patients in this study. Group A mono-infected with Hepatitis B, and those with co-infection HBV/HIV.
  • 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
  • To be HIV/HBV co-infected
  • All patients:
  • To be over 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Alfred Hospital, Commercial Road

Melbourne, Victoria, 3004, Australia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Conditions

Hepatitis BHIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Sharon Lewin, Professor

    Burnet Institute, Melbourne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Jennifer Hoy

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

December 1, 2004

Study Completion

December 1, 2009

Last Updated

January 20, 2012

Record last verified: 2012-01

Locations

AU(1)