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

NCT ID: NCT00662194

Last Updated: 2014-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2014-10-31

Brief Summary

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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

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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

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HIV-hepatitis Co-infection HIV Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1

HIV-HBV co-infected and receiving anti-retroviral therapy (ART) and CD4 count \> 500cells/mm3

No interventions assigned to this group

2

HIV-HBV co-infected and receiving ART and CD4 count 200-500 cells/mm3

No interventions assigned to this group

3

HIV-HBV co-infected and receiving ART and CD4 count \<200cells/mm3

No interventions assigned to this group

4

HIV-HBV co-infected and not receiving ART

No interventions assigned to this group

5

HIV-HCV co-infected \& receiving anti-retroviral therapy (ART) and CD4 count \> 500cells/mm3

No interventions assigned to this group

6

HIV-HCV co-infected and receiving ART and CD4 count 200-500 cells/mm3

No interventions assigned to this group

7

HIV-HCV co-infected and receiving ART and CD4 count \<200cells/mm3

No interventions assigned to this group

8

HIV-HCV co-infected and not receiving ART

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Monash Medical Centre

OTHER

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Bayside Health

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joe Sasadeusz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Alfred

Locations

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The Alfred Hospital

Melbourne, Victoria, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Jennifer Audsley, PhD

Role: CONTACT

+613 99030184

Facility Contacts

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Jennifer Audsley, PhD

Role: primary

+613 99030184

Other Identifiers

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ALF-55/08

Identifier Type: -

Identifier Source: org_study_id

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