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HIV-HBV Co-Infection and Liver Disease

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00637429
Enrollment
70
Registered
2008-03-18
Start date
2007-11-30
Completion date
Unknown
Last updated
2008-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-HBV Co-Infection, HIV Infections

Brief 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.

Interventions

None listed

Sponsors

Centre for Clinical Research Excellence in Infectious Diseases, Parkville
CollaboratorUNKNOWN
Gilead Sciences
CollaboratorINDUSTRY
Bayside Health
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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

MeasureTime frame
The surveillance of antiviral resistance mutations that may develop in those individuals who are unable to sustain hepatitis B suppression6 monthly assessment for 5 years

Countries

Australia

Contacts

Primary ContactJennifer Audsley, PhD
jennifer.audsley@med.monash.edu.au+613 99030184

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026