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| Sponsors and Collaborators: |
Bayside Health Monash University National Institutes of Health (NIH) |
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| Information provided by: | Bayside Health |
| ClinicalTrials.gov Identifier: | NCT00662194 |
Purpose
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.
| Condition |
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HIV-Hepatitis co-Infection HIV Infections |
| Study Type: | Observational |
| Study Design: | Cohort, Cross-Sectional |
| Official Title: | A Study of Innate Immunity in HIV Positive Patients co-Infected With Hepatitis C or Hepatitis B |
Serum samples
| Estimated Enrollment: | 40 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | October 2010 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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1
HIV-HBV co-infected and receiving anti-retroviral therapy (ART) and CD4 count > 500cells/mm3
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2
HIV-HBV co-infected and receiving ART and CD4 count 200-500 cells/mm3
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3
HIV-HBV co-infected and receiving ART and CD4 count <200cells/mm3
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4
HIV-HBV co-infected and not receiving ART
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5
HIV-HCV co-infected & receiving anti-retroviral therapy (ART) and CD4 count > 500cells/mm3
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6
HIV-HCV co-infected and receiving ART and CD4 count 200-500 cells/mm3
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7
HIV-HCV co-infected and receiving ART and CD4 count <200cells/mm3
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8
HIV-HCV co-infected and not receiving ART
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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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
primary care clinics
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jennifer Audsley, PhD | +613 99030184 | jennifer.audsley@med.monash.edu.au |
| Australia, Victoria | |
| The Alfred Hospital | Recruiting |
| Melbourne, Victoria, Australia, 3004 | |
| Contact: Jennifer Audsley, PhD +613 99030184 jennifer.audsley@med.monash.edu.au | |
| Sub-Investigator: David Iser, MD | |
| Principal Investigator: Joe Sasadeusz, MD, PhD | |
| Principal Investigator: | Joe Sasadeusz, MD, PhD | The Alfred Hospital |
More Information
| Responsible Party: | The Alfred Hospital ( Dr Joe Sasdeusz ) |
| Study ID Numbers: | ALF-55/08 |
| Study First Received: | April 17, 2008 |
| Last Updated: | May 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00662194 |
| Health Authority: | Australia: National Health and Medical Research Council |
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HIV HBV HCV co-infection innate immunity |
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Sexually Transmitted Diseases, Viral Liver Diseases Acquired Immunodeficiency Syndrome Hepatitis, Viral, Human Immunologic Deficiency Syndromes Hepatitis Virus Diseases Digestive System Diseases |
HIV Seropositivity HIV Infections Sexually Transmitted Diseases Hepatitis B DNA Virus Infections Hepatitis C Retroviridae Infections |
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Communicable Diseases RNA Virus Infections Slow Virus Diseases Flaviviridae Infections |
Immune System Diseases Lentivirus Infections Infection Hepadnaviridae Infections |
