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HIV-HBV Co-Infection and Liver Disease

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ClinicalTrials.gov Identifier: NCT00637429
Recruitment Status : Unknown
Verified March 2008 by Bayside Health.
Recruitment status was:  Recruiting
First Posted : March 18, 2008
Last Update Posted : April 2, 2008
Information provided by:

Study Description
Brief Summary:

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 or disease
HIV Infections HIV-HBV Co-Infection

Study Design

Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Human Immunodeficiency Virus (HIV) and Hepatitis B Virus (HBV) co-Infection and Liver Disease
Study Start Date : November 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

General Co-infection
Individuals with HIV infection and hepatitis B surface antigen positive results who are currently receiving or planning to commence HAART.

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples Without DNA
serum samples

Eligibility Criteria

Information from the National Library of Medicine

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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
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00637429

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

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
Principal Investigator: Sharon R Lewin, MD, PhD The Alfred Hospital, Melbourne & Monash University
More Information

Responsible Party: Professor Sharon Lewin, The Alfred Hospital and Monash University
ClinicalTrials.gov Identifier: NCT00637429     History of Changes
Other Study ID Numbers: ALF-263/06
First Posted: March 18, 2008    Key Record Dates
Last Update Posted: April 2, 2008
Last Verified: March 2008

Additional relevant MeSH terms:
Communicable Diseases
HIV Infections
Liver Diseases
Hepatitis B
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Digestive System Diseases
Parasitic Diseases
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Viral, Human