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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00637429




Registration number
NCT00637429
Ethics application status
Date submitted
11/03/2008
Date registered
18/03/2008
Date last updated
2/04/2008

Titles & IDs
Public title
HIV-HBV Co-Infection and Liver Disease
Scientific title
Human Immunodeficiency Virus (HIV) and Hepatitis B Virus (HBV) co-Infection and Liver Disease
Secondary ID [1] 0 0
ALF-263/06
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 0 0
HIV-HBV Co-Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 0 0 0 0
Liver

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
General Co-infection - Individuals with HIV infection and hepatitis B surface antigen positive results who are currently receiving or planning to commence HAART.

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
6 monthly assessment for 5 years
Secondary outcome [1] 0 0
The surveillance of antiviral resistance mutations that may develop in those individuals who are unable to sustain hepatitis B suppression
Timepoint [1] 0 0
6 monthly assessment for 5 years

Eligibility
Key inclusion criteria
- 18 years of age and older

- HIV positive

- 2 positive Hepatitis B surface antigen results 6 months apart

- provision of informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- unable to provide informed consent

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Centre for Clinical Research Excellence in Infectious Diseases, Parkville
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Gilead Sciences
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00637429
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sharon R Lewin, MD, PhD
Address 0 0
The Alfred Hospital, Melbourne & Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jennifer Audsley, PhD
Address 0 0
Country 0 0
Phone 0 0
+613 99030184
Fax 0 0
Email 0 0
jennifer.audsley@med.monash.edu.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00637429