HIV-HBV Co-Infection and Liver Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Bayside Health.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Centre for Clinical Research Excellence in Infectious Diseases, Parkville
Gilead Sciences
Information provided by:
Bayside Health
ClinicalTrials.gov Identifier:
NCT00637429
First received: March 11, 2008
Last updated: April 1, 2008
Last verified: March 2008
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by Bayside Health:

Primary Outcome Measures:
  • 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 ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637429

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

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
Coinfection
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
Infection
Parasitic Diseases
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Viral, Human
Hepatitis

ClinicalTrials.gov processed this record on August 21, 2014