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Sponsors and Collaborators: |
Bayside Health Centre for Clinical Research Excellence in Infectious Diseases, Parkville Gilead Sciences |
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Information provided by: | Bayside Health |
ClinicalTrials.gov Identifier: | NCT00637429 |
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 |
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HIV Infections HIV-HBV Co-Infection |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Human Immunodeficiency Virus (HIV) and Hepatitis B Virus (HBV) co-Infection and Liver Disease |
serum samples
Estimated Enrollment: | 70 |
Study Start Date: | November 2007 |
Groups/Cohorts |
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General Co-infection
Individuals with HIV infection and hepatitis B surface antigen positive results who are currently receiving or planning to commence HAART.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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:
Exclusion Criteria:
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 |
Principal Investigator: | Sharon R Lewin, MD, PhD | The Alfred Hospital, Melbourne & Monash University |
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 |
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 |
Communicable Diseases RNA Virus Infections Slow Virus Diseases |
Immune System Diseases Lentivirus Infections Infection |