Innate Immunity in HIV Positive Patients Co-infected With Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV)
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 Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||A Study of Innate Immunity in HIV Positive Patients Co-infected With Hepatitis C or Hepatitis B|
- TLR change with HIV co-infection therapy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- TLR change patterns on spontaneously and on treatment resolved HBV or HCV in the co-infected setting [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
|Study Start Date:||April 2008|
|Estimated Study Completion Date:||October 2014|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
HIV-HBV co-infected and receiving anti-retroviral therapy (ART) and CD4 count > 500cells/mm3
HIV-HBV co-infected and receiving ART and CD4 count 200-500 cells/mm3
HIV-HBV co-infected and receiving ART and CD4 count <200cells/mm3
HIV-HBV co-infected and not receiving ART
HIV-HCV co-infected & receiving anti-retroviral therapy (ART) and CD4 count > 500cells/mm3
HIV-HCV co-infected and receiving ART and CD4 count 200-500 cells/mm3
HIV-HCV co-infected and receiving ART and CD4 count <200cells/mm3
HIV-HCV co-infected and not receiving ART
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00662194
|Contact: Jennifer Audsley, PhD||+613 firstname.lastname@example.org|
|The Alfred Hospital||Recruiting|
|Melbourne, Victoria, Australia, 3004|
|Contact: Jennifer Audsley, PhD +613 99030184 email@example.com|
|Sub-Investigator: David Iser, MD|
|Principal Investigator: Joe Sasadeusz, MD, PhD|
|Principal Investigator:||Joe Sasadeusz, MD, PhD||The Alfred Hospital|