HIV-HBV Co-Infection and Liver Disease
Recruitment status was Recruiting
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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: | Observational Model: Cohort Time Perspective: Prospective |
Official Title: | Human Immunodeficiency Virus (HIV) and Hepatitis B Virus (HBV) co-Infection and Liver Disease |
- 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 ]
- 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
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.
|
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:
- 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
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 |
No publications provided
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 |
Study First Received: | March 11, 2008 |
Last Updated: | April 1, 2008 |
Health Authority: | Australia: National Health and Medical Research Council |
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome HIV Infections Liver Diseases Hepatitis B Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases Digestive System Diseases Hepadnaviridae Infections DNA Virus Infections Hepatitis, Viral, Human Hepatitis |
ClinicalTrials.gov processed this record on February 28, 2013