HIV-hepatitis Co-infectionNCT00662194
Innate Immunity in HIV Positive Patients Co-infected With Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV)
An observational study of HIV-hepatitis Co-infection and HIV Infections, run by Bayside Health at 1 site in Australia.
Trial summary
Data from this study will provide the first information how the innate immune system may be altered in HIV-HCV and HIV-HBV co-infected individuals, and describe Toll-like receptor changes with HIV co-infection therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-hepatitis Co-infection, HIV Infections
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- Apr 2008to Oct 2014
- 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: primary care clinics
Who may be able to join
- HIV and either HBV or HCV co-infection
- 18 years and older
- able to give informed consent
Who cannot join
- HIV-HBV-HCV triple infection
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
The Alfred Hospital
Melbourne, Victoria, 3004
Jennifer Audsley, PhD, +613 99030184, jennifer.audsley@med.monash.edu.au
David Iser, MD
About this study
Official title: A Study of Innate Immunity in HIV Positive Patients Co-infected With Hepatitis C or Hepatitis B
Data from this study will provide the first information how the innate immune system may be altered in HIV-HCV and HIV-HBV co-infected individuals, and describe Toll-like receptor changes with HIV co-infection therapy.
Read the detailed description
It has been demonstrated that Toll-like receptors (TLR) are involved in viral hepatitis - hepatitis B (HBV), hepatitis C (HCV) - and HIV in the setting of mono-infection. However the role of innate immunity in the pathogenesis of HIV-hepatitis co-infection in both natural and therapy-associated viral clearance remains unclear. The data from this study may reveal patterns which could predict how and when patients spontaneously, and with therapy, resolve HBV or HCV in the setting of co-infection.
The aim of the study is to evaluate the activity of innate immunity in different subsets of HIV-infected populations co-infected with chronic hepatitis B and/or C. Our hypothesis is that innate immunity is altered in HIV and hepatitis co-infection and that this differs from both hepatitis and HIV mono-infection.
The study is a cross-sectional and longitudinal pilot study of individuals infected with HIV and either HBV or HCV.
- Conditions
- HIV-hepatitis Co-infection, HIV Infections
- Keywords
- HIV, HBV, HCV, co-infection, innate immunity
- Medical subject headings
- HIV Infections, Coinfection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | HIV-HBV co-infected and receiving anti-retroviral therapy (ART) and CD4 count > 500cells/mm3 | |
| 2 | HIV-HBV co-infected and receiving ART and CD4 count 200-500 cells/mm3 | |
| 3 | HIV-HBV co-infected and receiving ART and CD4 count <200cells/mm3 | |
| 4 | HIV-HBV co-infected and not receiving ART | |
| 5 | HIV-HCV co-infected \& receiving anti-retroviral therapy (ART) and CD4 count > 500cells/mm3 | |
| 6 | HIV-HCV co-infected and receiving ART and CD4 count 200-500 cells/mm3 | |
| 7 | HIV-HCV co-infected and receiving ART and CD4 count <200cells/mm3 | |
| 8 | HIV-HCV co-infected and not receiving ART |
What is being measured
The primary outcome is the main question the study is designed to answer.
TLR change with HIV co-infection therapy
Measured: 6 months
Secondary outcomes (1)
TLR change patterns on spontaneously and on treatment resolved HBV or HCV in the co-infected setting
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionApr 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-hepatitis Co-infectionStudies 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
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Collaborators
- Monash Medical Centre, National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Joe Sasadeusz, MD, PhD, Principal investigator, The Alfred
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00662194
- Sponsor's protocol ID
- ALF-55/08
- Status last verified
- Mar 2014
- First submitted
- 17 Apr 2008
- Last updated
- 10 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Innate Immunity in HIV Positive Patients Co-infected With Hepatitis C or Hepatitis B
- ClinicalTrials.gov ID
- NCT00662194
- Acronym / sponsor ID
- ALF-55/08
- Conditions
- HIV-hepatitis Co-infection, HIV Infections
- Keywords
- HIV, HBV, HCV, co-infection, innate immunity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Bayside HealthOther government
- Collaborators
- Monash Medical Centre, National Institutes of Health (NIH)
- Study start
- Apr 2008
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 21 Apr 2008 (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.
Data from this study will provide the first information how the innate immune system may be altered in HIV-HCV and HIV-HBV co-infected individuals, and describe Toll-like receptor changes with HIV co-infection therapy.
Detailed description
It has been demonstrated that Toll-like receptors (TLR) are involved in viral hepatitis - hepatitis B (HBV), hepatitis C (HCV) - and HIV in the setting of mono-infection. However the role of innate immunity in the pathogenesis of HIV-hepatitis co-infection in both natural and therapy-associated viral clearance remains unclear. The data from this study may reveal patterns which could predict how and when patients spontaneously, and with therapy, resolve HBV or HCV in the setting of co-infection.
The aim of the study is to evaluate the activity of innate immunity in different subsets of HIV-infected populations co-infected with chronic hepatitis B and/or C. Our hypothesis is that innate immunity is altered in HIV and hepatitis co-infection and that this differs from both hepatitis and HIV mono-infection.
The study is a cross-sectional and longitudinal pilot study of individuals infected with HIV and either HBV or HCV.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –HIV-HBV co-infected and receiving anti-retroviral therapy (ART) and CD4 count > 500cells/mm3 |
| 2 | – | –HIV-HBV co-infected and receiving ART and CD4 count 200-500 cells/mm3 |
| 3 | – | –HIV-HBV co-infected and receiving ART and CD4 count <200cells/mm3 |
| 4 | – | –HIV-HBV co-infected and not receiving ART |
| 5 | – | –HIV-HCV co-infected \& receiving anti-retroviral therapy (ART) and CD4 count > 500cells/mm3 |
| 6 | – | –HIV-HCV co-infected and receiving ART and CD4 count 200-500 cells/mm3 |
| 7 | – | –HIV-HCV co-infected and receiving ART and CD4 count <200cells/mm3 |
| 8 | – | –HIV-HCV co-infected and not receiving ART |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinics
Key inclusion criteria (3 listed)
- HIV and either HBV or HCV co-infection
- 18 years and older
- able to give informed consent
Key exclusion criteria (1 listed)
- HIV-HBV-HCV triple infection
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
TLR change with HIV co-infection therapy
Time frame: 6 months
1 secondary outcome
TLR change patterns on spontaneously and on treatment resolved HBV or HCV in the co-infected setting
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2014.
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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.
Joe Sasadeusz, MD, PhD principal investigator
The Alfred
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 HIV-hepatitis Co-infection and HIV Infections, run by Bayside Health 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 3 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: status not confirmed, as of the sponsor's last update on 10 Mar 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Audsley, PhD (+613 99030184, jennifer.audsley@med.monash.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TLR change with HIV co-infection therapy (time frame: 6 months). It is what the study was designed to measure, not a finding.
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 10 Mar 2014.