HIV-HBV Co-Infection and Liver Disease

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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
Last Update Posted:	April 2, 2008
Last Verified:	March 2008

Additional relevant MeSH terms:

HIV Infections; Infection; Communicable Diseases; Liver Diseases; Coinfection; 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; Hepatitis