HIV-HBV Co-Infection and Liver Disease

NCT00637429 | Unknown

• 1 other identifier: ALF-263/06
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; HIV-HBV Co-Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

General Co-infection

Individuals with HIV infection and hepatitis B surface antigen positive results who are currently receiving or planning to commence HAART.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• years of age and older
• HIV positive
• positive Hepatitis B surface antigen results 6 months apart
• provision of informed consent

You may not qualify if:

• unable to provide informed consent

Sponsors & Collaborators

• Bayside Health: lead
• Centre for Clinical Research Excellence in Infectious Diseases, Parkville: collaborator
• Gilead Sciences: collaborator

Study Sites (1)

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum samples

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Sharon R Lewin, MD, PhD

  The Alfred Hospital, Melbourne & Monash University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Audsley, PhD

CONTACT

+613 99030184; jennifer.audsley@med.monash.edu.au

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: March 11, 2008
• First Posted: March 18, 2008
• Study Start: November 1, 2007
• Last Updated: April 2, 2008

Record last verified: 2008-03

Locations

AU (1)