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

This study is currently recruiting participants. (see Contacts and Locations)
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
  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
HIV-hepatitis Co-infection
HIV Infections

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Bayside Health:

Primary Outcome Measures:
  • TLR change with HIV co-infection therapy [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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

Serum samples


Estimated Enrollment: 40
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)
Groups/Cohorts
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

Detailed Description:

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
Study Population

primary care clinics

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662194

Contacts
Contact: Jennifer Audsley, PhD +613 99030184 jennifer.audsley@med.monash.edu.au

Locations
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         
Sponsors and Collaborators
Bayside Health
Monash Medical Centre
Investigators
Principal Investigator: Joe Sasadeusz, MD, PhD The Alfred Hospital
  More Information

No publications provided

Responsible Party: Bayside Health
ClinicalTrials.gov Identifier: NCT00662194     History of Changes
Other Study ID Numbers: ALF-55/08
Study First Received: April 17, 2008
Last Updated: March 6, 2014
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by Bayside Health:
HIV
HBV
HCV
co-infection
innate immunity

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Coinfection
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis C
HIV Infections
HIV Seropositivity
Hepatitis, Viral, Human
Communicable Diseases
Infection
Digestive System Diseases
DNA Virus Infections
Enterovirus Infections
Flaviviridae Infections
Hepadnaviridae Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Liver Diseases
Parasitic Diseases
Picornaviridae Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 20, 2014