HIV-HBV Co-Infection and Liver Disease
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|ClinicalTrials.gov Identifier: NCT00637429|
Recruitment Status : Unknown
Verified March 2008 by Bayside Health.
Recruitment status was: Recruiting
First Posted : March 18, 2008
Last Update Posted : April 2, 2008
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 or disease|
|HIV Infections HIV-HBV Co-Infection|
|Study Type :||Observational|
|Estimated Enrollment :||70 participants|
|Official Title:||Human Immunodeficiency Virus (HIV) and Hepatitis B Virus (HBV) co-Infection and Liver Disease|
|Study Start Date :||November 2007|
Individuals with HIV infection and hepatitis B surface antigen positive results who are currently receiving or planning to commence HAART.
- 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 ]
- 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 ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00637429
|Contact: Jennifer Audsley, PhD||+613 firstname.lastname@example.org|
|The Alfred Hospital||Recruiting|
|Melbourne, Victoria, Australia, 3004|
|Contact: Jennifer Audsley, PhD +613 99030184 email@example.com|
|Principal Investigator: Sharon Lewin|
|Principal Investigator: Joe Sasadeusz|
|Sub-Investigator: Jennifer Hoy|
|Sub-Investigator: David Iser|
|Sub-Investigator: Jennifer Audsley|
|Principal Investigator:||Sharon R Lewin, MD, PhD||The Alfred Hospital, Melbourne & Monash University|