Try our beta test site
Trial record 1 of 1 for:    NCT00662194
Previous Study | Return to List | Next Study

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. The completion date has passed and the status has not been verified in more than two years.
Verified March 2014 by Bayside Health.
Recruitment status was:  Recruiting
Monash Medical Centre
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Bayside Health Identifier:
First received: April 17, 2008
Last updated: March 6, 2014
Last verified: March 2014
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.

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 ]

Secondary Outcome Measures:
  • TLR change patterns on spontaneously and on treatment resolved HBV or HCV in the co-infected setting [ Time Frame: 6 months ]

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)
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

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary care clinics

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 identifier: NCT00662194

Australia, Victoria
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Bayside Health
Monash Medical Centre
National Institutes of Health (NIH)
Principal Investigator: Joe Sasadeusz, MD, PhD The Alfred
  More Information

Responsible Party: Bayside Health Identifier: NCT00662194     History of Changes
Other Study ID Numbers: ALF-55/08 
Study First Received: April 17, 2008
Last Updated: March 6, 2014

Keywords provided by Bayside Health:
innate immunity

Additional relevant MeSH terms:
Communicable Diseases
Hepatitis C
Hepatitis A
HIV Infections
Hepatitis B
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Liver Diseases
Digestive System Diseases
Enterovirus Infections
Picornaviridae Infections
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Parasitic Diseases processed this record on February 20, 2017