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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by Bayside Health.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Monash Medical Centre
National Institutes of Health (NIH)
Information provided by:
Bayside Health
ClinicalTrials.gov Identifier:
NCT00662194
First received: April 17, 2008
Last updated: May 8, 2008
Last verified: April 2008
History of Changes
  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:

U.S. FDA Resources

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 2010
Estimated Primary Completion Date: April 2010 (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
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
National Institutes of Health (NIH)
Investigators
Principal Investigator: Joe Sasadeusz, MD, PhD The Alfred Hospital
  More Information

No publications provided

Responsible Party: Dr Joe Sasdeusz, The Alfred Hospital
ClinicalTrials.gov Identifier: NCT00662194     History of Changes
Other Study ID Numbers: ALF-55/08
Study First Received: April 17, 2008
Last Updated: May 8, 2008
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:
HIV Infections
Acquired Immunodeficiency Syndrome
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis C
HIV Seropositivity
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
 Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Hepadnaviridae Infections
DNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on February 28, 2013