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HIV-HBV Co-Infection and Liver Disease
This study is currently recruiting participants.
Verified by Bayside Health, March 2008
Sponsors and Collaborators: Bayside Health
Centre for Clinical Research Excellence in Infectious Diseases, Parkville
Gilead Sciences
Information provided by: Bayside Health
ClinicalTrials.gov Identifier: NCT00637429
  Purpose

Human immunodeficiency virus/Hepatitis B virus (HIV/HBV) co-infections are frequently observed due to shared routes of transmission, with reported figures indicating 6-9% of HIV-infected individuals in developed countries are chronically infected with HBV. HIV infection impacts on the natural progression of HBV infection, increasing levels of HBV replication and the risk of liver-associated mortality. Liver diseases associated with HBV are affected by the antiviral drugs used for HIV infection (toxic side effects), the current immune function in the patient, by improvements in the immune system brought about by control of the HIV infection, and by the development of resistance to the antiviral agents used for both the hepatitis B and the HIV infection. Co-infection with HBV increases the risk for hepatotoxicity in those individuals receiving highly active antiretroviral therapy (HAART) for their HIV infection.

This study will recruit patients who are co-infected with HIV and HBV, and are currently taking or who are about to commence HAART. The study cohort will include HIV-HBV co-infected individuals from the Alfred Hospital, the Royal Melbourne Hospital and high case load GP clinics who are referred to the Alfred Hospital.

The aim of the study is to investigate chronic hepatitis B and its impact on the progression of liver disease in HIV-infected persons receiving HAART.

This will be achieved by 6 monthly assessment with medical history, physical examination, bloods for markers of liver disease and hepatitis B activity and completion of questionnaires to measure adherence and alcohol use.


Condition
HIV Infections
HIV-HBV Co-Infection

MedlinePlus related topics: AIDS Hepatitis Hepatitis B Liver Diseases
Drug Information available for: Hepatitis B Vaccines
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Human Immunodeficiency Virus (HIV) and Hepatitis B Virus (HBV) co-Infection and Liver Disease

Further study details as provided by Bayside Health:

Primary Outcome Measures:
  • To investigate the efficacy and sustainability of HBV-active HAART on hepatitis B suppression by measuring changes in the HBV DNA levels as well as monitoring ALT levels, CD4 counts and HBV serology results. [ Time Frame: 6 monthly assessment for 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The surveillance of antiviral resistance mutations that may develop in those individuals who are unable to sustain hepatitis B suppression [ Time Frame: 6 monthly assessment for 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

serum samples


Estimated Enrollment: 70
Study Start Date: November 2007
Groups/Cohorts
General Co-infection
Individuals with HIV infection and hepatitis B surface antigen positive results who are currently receiving or planning to commence HAART.

  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

HIV-HBV co-infected individuals from the Alfred Hospital, the Royal Melbourne Hospital and high case load GP clinics who are referred to the Alfred Hospital

Criteria

Inclusion Criteria:

  • 18 years of age and older
  • HIV positive
  • 2 positive Hepatitis B surface antigen results 6 months apart
  • provision of informed consent

Exclusion Criteria:

  • unable to provide informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00637429

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    
Principal Investigator: Sharon Lewin            
Principal Investigator: Joe Sasadeusz            
Sub-Investigator: Jennifer Hoy            
Sub-Investigator: David Iser            
Sub-Investigator: Jennifer Audsley            
Sponsors and Collaborators
Bayside Health
Centre for Clinical Research Excellence in Infectious Diseases, Parkville
Gilead Sciences
Investigators
Principal Investigator: Sharon R Lewin, MD, PhD The Alfred Hospital, Melbourne & Monash University
  More Information

Responsible Party: The Alfred Hospital and Monash University ( Professor Sharon Lewin )
Study ID Numbers: ALF-263/06
Study First Received: March 11, 2008
Last Updated: April 1, 2008
ClinicalTrials.gov Identifier: NCT00637429  
Health Authority: Australia: National Health and Medical Research Council

Study placed in the following topic categories:
Virus Diseases
Hepatitis
Sexually Transmitted Diseases, Viral
Liver Diseases
Digestive System Diseases
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Hepatitis B
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Communicable Diseases
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009