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HIV-HBV Co-Infection and Liver Disease

B

Bayside Health

Status

Unknown

Conditions

HIV-HBV Co-Infection
HIV Infections

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT00637429
ALF-263/06

Details and patient eligibility

About

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.

Enrollment

70 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

70 participants in 1 patient group

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

Trial contacts and locations

1

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Central trial contact

Jennifer Audsley, PhD

Data sourced from clinicaltrials.gov

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