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

This study is currently recruiting participants.
Verified March 2014 by Bayside Health
Sponsor:
Collaborators:
Monash Medical Centre
Information provided by (Responsible Party):
Bayside Health
ClinicalTrials.gov Identifier:
NCT00662194
First received: April 17, 2008
Last updated: March 6, 2014
Last verified: March 2014

April 17, 2008
March 6, 2014
April 2008
April 2014   (final data collection date for primary outcome measure)
TLR change with HIV co-infection therapy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00662194 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Innate Immunity in HIV Positive Patients Co-infected With Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV)
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples Without DNA
Description:

Serum samples

Non-Probability Sample

primary care clinics

  • HIV-hepatitis Co-infection
  • HIV Infections
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
October 2014
April 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Jennifer Audsley, PhD +613 99030184 jennifer.audsley@med.monash.edu.au
Australia
 
NCT00662194
ALF-55/08
No
Bayside Health
Bayside Health
  • Monash Medical Centre
  • National Institutes of Health (NIH)
Principal Investigator: Joe Sasadeusz, MD, PhD The Alfred Hospital
Bayside Health
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP