NCT00168194

Completed

Cellular Immune Responses to Hepatitis B Virus (HBV)- Longit...

The Alfred Source

Other study identifiers

Sponsor study identifier

235/04

Study Type

observational

Actual enrollment (reported)

104

Locations

1 country

Sites

1

Timeline

Study Start

December 2004

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

December 2009

Actual (reported)

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 104 participants
Study completion date: December 2009
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
December 2004
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 9, 2005
Actual (reported)
First Posted
September 15, 2005
Actual (reported)
Study Completion
December 2009
Actual (reported)

Last Updated: January 20, 2012
Status Verified: January 2012
Last Update Submitted: January 19, 2012

Conditions

Hepatitis B HIV 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

Sponsors & Collaborators

The Alfred
Otherlead
National Institutes of Health (NIH)
NIHcollaborator

Study Sites (1)

The Alfred Hospital, Commercial Road

Melbourne, Victoria, 3004, Australia

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 Infections

Study Officials

Sharon Lewin, Professor
Burnet Institute, Melbourne
PRINCIPAL INVESTIGATOR

Enrollment

104 participants (actual enrollment reported by the registry).

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 2004

Date type not reported

This date has not been verified as actual or estimated.

NCT00100633

Safety of and Immune Response to a Hepatitis B Virus Vaccine Given With a Booster (CpG7909 ODN) in HIV Infected and HIV Uninfected People

Phase 1/2Completed

NCT00051090

Treatment of Hepatitis B Virus (HBV) Before Beginning Anti-HIV Drugs in Patients With Both HBV and HIV

Not ApplicableWithdrawn

NCT00391638

Efficacy and Tolerance of Peg-interferon Alpha 2a Added to Tenofovir and Emtricitabine in AgHBe Positive HBV-HIV Co-infected Patients

Phase 2/3Completed

NCT04193189

B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B

Phase 3Completed

NCT00782158

Hepatitis B and HIV Co-Infection in Patients in Uganda

Completed

NCT00013702

Adefovir Dipivoxil to Treat Hepatitis B in HIV-Infected Patients

Phase 2Completed

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.

Retroviridae Infections

RNA Virus Infections

Genital Diseases

Urogenital Diseases

Immunologic Deficiency Syndromes

Immune System Diseases

Study Completion

December 2009

Actual (reported)

Last Updated

January 20, 2012

Record last verified: 2012-01

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00168194
Data provider: ClinicalTrials.gov
Source updated: 2012-01-20
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:19:45 UTC

Locations

AU(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Keywords

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations