HIV-HBV Co-Infection and Liver Disease
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|ClinicalTrials.gov Identifier: NCT00637429|
Recruitment Status : Unknown
Verified March 2008 by Bayside Health.
Recruitment status was: Recruiting
First Posted : March 18, 2008
Last Update Posted : April 2, 2008
|First Submitted Date||March 11, 2008|
|First Posted Date||March 18, 2008|
|Last Update Posted Date||April 2, 2008|
|Study Start Date||November 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||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 ]|
|Original Primary Outcome Measures||Same as current|
|Change History||Complete list of historical versions of study NCT00637429 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures
||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 ]|
|Original Secondary Outcome Measures||Same as current|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||HIV-HBV Co-Infection and Liver Disease|
|Official Title||Human Immunodeficiency Virus (HIV) and Hepatitis B Virus (HBV) co-Infection and Liver Disease|
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 Design||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Biospecimen||Retention: Samples Without DNA
|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|
|Study Groups/Cohorts||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 Status||Unknown status|
|Original Estimated Enrollment||Same as current|
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Ages||18 Years and older (Adult, Older Adult)|
|Accepts Healthy Volunteers||No|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||Australia|
|Removed Location Countries|
|Other Study ID Numbers||ALF-263/06|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Professor Sharon Lewin, The Alfred Hospital and Monash University|
|Study Sponsor||Bayside Health|
|PRS Account||Bayside Health|
|Verification Date||March 2008|