Innate Immunity in HIV Positive Patients Co-infected With Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV)

March 6, 2014 updated by: Bayside Health

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • The Alfred Hospital
        • Contact:
        • Sub-Investigator:
          • David Iser, MD
        • Principal Investigator:
          • Joe Sasadeusz, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

primary care clinics

Description

Inclusion Criteria:

  • HIV and either HBV or HCV co-infection
  • 18 years and older
  • able to give informed consent

Exclusion Criteria:

  • HIV-HBV-HCV triple infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
TLR change with HIV co-infection therapy
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
TLR change patterns on spontaneously and on treatment resolved HBV or HCV in the co-infected setting
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayside Health

Collaborators

National Institutes of Health (NIH)
Monash Medical Centre

Investigators

  • Principal Investigator: Joe Sasadeusz, MD, PhD, The Alfred

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Anticipated)

April 1, 2014

Study Completion (Anticipated)

October 1, 2014

Study Registration Dates

First Submitted

April 17, 2008

First Submitted That Met QC Criteria

April 18, 2008

First Posted (Estimate)

April 21, 2008

Study Record Updates

Last Update Posted (Estimate)

March 10, 2014

Last Update Submitted That Met QC Criteria

March 6, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALF-55/08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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