HIV-HBV Co-Infection and Liver Disease

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2008 by Bayside Health.
Recruitment status was Recruiting

Sponsor:

Collaborators:

Centre for Clinical Research Excellence in Infectious Diseases, Parkville

Gilead Sciences

Information provided by:

Bayside Health

ClinicalTrials.gov Identifier:

NCT00637429

First received: March 11, 2008

Last updated: April 1, 2008

Last verified: March 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

March 11, 2008

Last Updated Date

April 1, 2008

Start Date ^ICMJE

November 2007

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00637429 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

HIV-HBV Co-Infection and Liver Disease

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples Without DNA

Description:

serum samples

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

Condition ^ICMJE

HIV Infections
HIV-HBV Co-Infection

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

General Co-infection

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Jennifer Audsley, PhD

+613 99030184

jennifer.audsley@med.monash.edu.au

Location Countries ^ICMJE

Australia

Administrative Information

NCT Number ^ICMJE

NCT00637429

Other Study ID Numbers ^ICMJE

ALF-263/06

Has Data Monitoring Committee

Responsible Party

Professor Sharon Lewin, The Alfred Hospital and Monash University

Study Sponsor ^ICMJE

Bayside Health

Collaborators ^ICMJE

Centre for Clinical Research Excellence in Infectious Diseases, Parkville
Gilead Sciences

Investigators ^ICMJE

Principal Investigator:

Sharon R Lewin, MD, PhD

The Alfred Hospital, Melbourne & Monash University

Information Provided By

Bayside Health

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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