HIV-HBV Co-Infection and Liver Disease

NCT ID: NCT00637429

Last Updated: 2008-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Infections HIV-HBV Co-Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre for Clinical Research Excellence in Infectious Diseases, Parkville

UNKNOWN

Sponsor Role collaborator

Gilead Sciences

INDUSTRY

Sponsor Role collaborator

Bayside Health

OTHER_GOV

Sponsor Role lead

Responsible Party

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The Alfred Hospital and Monash University

Principal Investigators

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Sharon R Lewin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Alfred Hospital, Melbourne & Monash University

Locations

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The Alfred Hospital

Melbourne, Victoria, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Jennifer Audsley, PhD

Role: CONTACT

Phone: +613 99030184

Email: [email protected]

Facility Contacts

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Jennifer Audsley, PhD

Role: primary

Other Identifiers

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ALF-263/06

Identifier Type: -

Identifier Source: org_study_id