HIV-HBV Co-Infection and Liver Disease

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00637429
• Other study ID #: ALF-263/06
• Status: Recruiting
• Phase: N/A
• First received: March 11, 2008
• Last updated: April 1, 2008
• Start date: November 2007

Study information

• Verified date: March 2008
• Source: Bayside Health
• Contact: Jennifer Audsley, PhD
• Phone: +613 99030184
• Email: jennifer.audsley[@]med.monash.edu.au
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Coinfection
• Communicable Diseases
• Hepatitis B
• HIV Infections
• HIV-HBV Co-Infection
• Infection
• Liver Diseases

Locations

Country	Name	City	State
Australia	The Alfred Hospital	Melbourne	Victoria

Sponsors (3)

Lead Sponsor	Collaborator
Bayside Health	Centre for Clinical Research Excellence in Infectious Diseases, Parkville, Gilead Sciences

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No