Hepatitis BNCT00168194
Cellular Immune Responses to Hepatitis B Virus (HBV)- Longitudinal Follow up and Natural History
An observational study of Hepatitis B and HIV Infections, run by The Alfred at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B, HIV Infections
- How many people
- 104 participants
- Where
- 1 siteAustralia
- Study dates
- Dec 2004to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV and hepatitis B co-infection
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- Those who do not fit the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
Australia1 site
The Alfred Hospital, Commercial Road
Melbourne, Victoria, 3004
About this study
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:
- 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.
- To determine the effect of HIV infection on HBV-specific T-cell responses
- Conditions
- Hepatitis B, HIV Infections
- Keywords
- HIV
- Medical subject headings
- Hepatitis B, HIV Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startDec 2004
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Alfred
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Jennifer Hoy, The Alfred
- Investigators
- Sharon Lewin, Professor, Principal investigator, Burnet Institute, Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00168194
- Sponsor's protocol ID
- 235/04
- Status last verified
- Jan 2012
- First submitted
- 9 Sep 2005
- Last updated
- 20 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cellular Immune Responses to Hepatitis B Virus (HBV)- Longitudinal Follow up and Natural History
- ClinicalTrials.gov ID
- NCT00168194
- Acronym / sponsor ID
- 235/04
- Conditions
- Hepatitis B, HIV Infections
- Keywords
- HIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- The AlfredUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Dec 2004
- Study completion
- Dec 2009 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- To determine the effect of HIV infection on HBV-specific T-cell responses
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV and hepatitis B co-infection
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (1 listed)
- Those who do not fit the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon Lewin, Professor principal investigator
Burnet Institute, Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B and HIV Infections, run by The Alfred at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2012.