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

March 11, 2008
April 1, 2008
November 2007
Not Provided
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 ]
Same as current
Complete list of historical versions of study NCT00637429 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

serum samples

Non-Probability Sample

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

  • HIV Infections
  • HIV-HBV Co-Infection
Not Provided
General Co-infection
Individuals with HIV infection and hepatitis B surface antigen positive results who are currently receiving or planning to commence HAART.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
Not Provided
Not Provided

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
Both
18 Years and older
No
Contact: Jennifer Audsley, PhD +613 99030184 jennifer.audsley@med.monash.edu.au
Australia
 
NCT00637429
ALF-263/06
No
Professor Sharon Lewin, The Alfred Hospital and Monash University
Bayside Health
  • Centre for Clinical Research Excellence in Infectious Diseases, Parkville
  • Gilead Sciences
Principal Investigator: Sharon R Lewin, MD, PhD The Alfred Hospital, Melbourne & Monash University
Bayside Health
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP