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

Study Overview
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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.

Official Title
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A Study of Innate Immunity in HIV Positive Patients Co-infected With Hepatitis C or Hepatitis B

Conditions
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HIV-hepatitis Co-infection, HIV Infections

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>HIV-HBV co-infected and receiving anti-retroviral therapy (ART) and CD4 count > 500cells/mm3 | |
| 2<br>HIV-HBV co-infected and receiving ART and CD4 count 200-500 cells/mm3 | |
| 3<br>HIV-HBV co-infected and receiving ART and CD4 count <200cells/mm3 | |
| 4<br>HIV-HBV co-infected and not receiving ART | |
| 5<br>HIV-HCV co-infected & receiving anti-retroviral therapy (ART) and CD4 count > 500cells/mm3 | |
| 6<br>HIV-HCV co-infected and receiving ART and CD4 count 200-500 cells/mm3 | |
| 7<br>HIV-HCV co-infected and receiving ART and CD4 count <200cells/mm3 | |
| 8<br>HIV-HCV co-infected and not receiving ART | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, HBV, HCV, co-infection, innate immunity