HIV-HBV Co-Infection and Liver Disease

Human Immunodeficiency Virus (HIV) and Hepatitis B Virus (HBV) co-Infection and Liver Disease

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.

Study Overview

• Status: Unknown
• Conditions: HIV Infections; HIV-HBV Co-Infection

• Study Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

• Study Contact: Name: Jennifer Audsley, PhD; Phone Number: +613 99030184; Email: jennifer.audsley@med.monash.edu.au

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Recruiting
      • The Alfred Hospital
      • Contact: Jennifer Audsley, PhD; Phone Number: +613 99030184; Email: 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	6 monthly assessment for 5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
The surveillance of antiviral resistance mutations that may develop in those individuals who are unable to sustain hepatitis B suppression	6 monthly assessment for 5 years

Collaborators and Investigators

• Sponsor: Bayside Health
• Collaborators: Gilead Sciences; Centre for Clinical Research Excellence in Infectious Diseases, Parkville
• Investigators: Principal Investigator: Sharon R Lewin, MD, PhD, The Alfred Hospital, Melbourne & Monash University

Study record dates

Study Major Dates

• Study Start: November 1, 2007

Study Registration Dates

• First Submitted: March 11, 2008
• First Submitted That Met QC Criteria: March 11, 2008
• First Posted (Estimate): March 18, 2008

Study Record Updates

• Last Update Posted (Estimate): April 2, 2008
• Last Update Submitted That Met QC Criteria: April 1, 2008
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Liver Diseases; Infections; Communicable Diseases; Coinfection
• Other Study ID Numbers: ALF-263/06