Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00660361




Registration number
NCT00660361
Ethics application status
Date submitted
16/04/2008
Date registered
17/04/2008
Date last updated
17/04/2008

Titles & IDs
Public title
A Surveillance Program for the Detection of Hepatitis B Virus (HBV) Resistance to Tenofovir in HIV-HBV co-Infected Patients
Scientific title
A Surveillance Program for the Detection of Hepatitis B Virus (HBV) Resistance to Tenofovir (TDF) in HIV-HBV co-Infected Patients
Secondary ID [1] 0 0
ALF-50/08
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 0 0
Hepatitis B Virus 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
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A - individuals co-infected with HIV-HBV and receiving tenofovir as aprt of their HAART regimen
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
- 18 years of age and older

- HIV positive

- 2 positive Hepatitis B surface antigen results at least 6 months apart

- currently receiving (or about to commence) tenofovir therapy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- unable to provide informed consent

- lack of a serum sample prior to commencing tenofovir

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
1/04/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2010
Actual
Sample size
Target
92
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
Commercial sector/Industry
Name [1] 0 0
Gilead Sciences
Address [1] 0 0
Country [1] 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. 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
Trial website
https://clinicaltrials.gov/ct2/show/NCT00660361
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sharon L, MD, PhD
Address 0 0
The Alfred Hospital and 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
613-9903-0184
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/ct2/show/NCT00660361