A Surveillance Program for the Detection of Hepatitis B Virus (HBV) Resistance to Tenofovir in HIV-HBV co-Infected Patients

NCT00660361 | Unknown

• 1 other identifier: ALF-50/08
• Study Type: observational
• Target: 92
• 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. Tenofovir (TDF) is a newer antiviral drug that is frequently used for HIV infection and is also highly active against hepatitis B; however it is still unknown whether resistance to TDF will eventually develop and how this will affect the long-term outcomes

Conditions

HIV Infections; Hepatitis B Virus

Keywords

HIV; HBV; co-infection; drug resistance; tenofovir; HIV-HBV co-infection

Study Arms (1)

A

individuals co-infected with HIV-HBV and receiving tenofovir as aprt of their HAART regimen

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

Individuals co-infected with HIV-HBV and currently receiving tenofovir as part of their HAART regimen

You may qualify if:

• years of age and older
• HIV positive
• positive Hepatitis B surface antigen results at least 6 months apart
• currently receiving (or about to commence) tenofovir therapy

You may not qualify if:

• unable to provide informed consent
• lack of a serum sample prior to commencing tenofovir

Sponsors & Collaborators

• Bayside Health: lead
• Gilead Sciences: collaborator

Study Sites (1)

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stored serum samples

MeSH Terms

Conditions

HIV Infections; Hepatitis B; Coinfection

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; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Sharon L, MD, PhD

  The Alfred Hospital and Monash University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Audsley, PhD

CONTACT

613-9903-0184; 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: April 16, 2008
• First Posted: April 17, 2008
• Study Start: April 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: September 1, 2010
• Last Updated: April 17, 2008

Record last verified: 2008-04

Locations

AU (1)