Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000436673
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
16/09/2005
Date last updated
25/11/2019
Date data sharing statement initially provided
25/11/2019
Date results provided
25/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Virological and clinical anti-HBV efficacy of tenofovir in antiretroviral naive patients with HIV/HBV co-infection
Scientific title
A randomised mulitcentre trial of tenofovir (TDF) vs lamividine (LAM) vs TDF/LAM in antiretroviral naive subjects with HIV/HBV conifection over 48 weeks.
Secondary ID [1] 299908 0
TICO
Universal Trial Number (UTN)
Trial acronym
TICO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Hepatitis B Coinfection 548 0
Condition category
Condition code
Infection 625 625 0 0
Acquired immune deficiency syndrome (AIDS / HIV)
Inflammatory and Immune System 626 626 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Tenofovir, Lamivudine over 48 weeks
Intervention code [1] 477 0
Treatment: Drugs
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 733 0
To compare HBV DNA suppression to levels below the limit of detection (<400 copies/ml) by week 48 in each group
Timepoint [1] 733 0
Secondary outcome [1] 1500 0
To evaluate the emergence of HBV resistance
Timepoint [1] 1500 0
At 48 weeks
Secondary outcome [2] 1501 0
To compare the proportion of patients with undetectable HBV DNA
Timepoint [2] 1501 0
At weeks 12 and 24 in each treatment group.
Secondary outcome [3] 1502 0
To compare the proportion of patients who achieve HBeAg and HBsAg seroconversion.
Timepoint [3] 1502 0
At weeks 24 and 48 during the study.
Secondary outcome [4] 1503 0
To compare changes in ALT from baseline and the rate of hepatic cytolysis (ALT > 5x ULN).
Timepoint [4] 1503 0
Secondary outcome [5] 1504 0
To compare suppression of HIV-1 RNA and changes in CD4/CD8 counts.
Timepoint [5] 1504 0
Over 48 weeks.
Secondary outcome [6] 1505 0
To compare the effect of therapy on histological changes in the liver and on the presence of ccc-DNA.
Timepoint [6] 1505 0

Eligibility
Key inclusion criteria
Written informed consent; Documented HIV infection (positive serology for HIV-1 and detectable HIV-1 RNA); HBV DNA > 105 copies/ml; HBsAg positive >6 months or HBsAg positive and anti HB core IgM negative; Creatinine <= 2.0mg/dl (<= 0.2 mmol/L); Platelet count >= 50,000/mm; HIV-1 antiretroviral therapy naive; No prior exposure to anti-HBV agents (LAM, adefovir, TDF) although prior IFN treatment allowed.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
HCV-RNA positive or Anti-HAV IgM positive-Acute hepatitis (serum ALT > 1000 U/L)-Active opportunistic infection-Other causes of chronic liver disease identified (autoimmune hepatitis, haemachromatosis, Wilsons disease, alfa-1-antitrypsin deficiency)-Concurrent malignancy requiring cytotoxic chemotherapy-Decompensated or Child's C cirrhosis-Alfa-fetoprotein (AFP) > 3X ULN (unless negative CT scan or MRI within 3 months of entry date)-Pregnancy or lactation-Any other condition which in the opinion of the investigator might interfere with compliance or outcome of the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Centrally randomised via fax
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
SAS, Permuted Blocks stratified site and CD count
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/01/2004
Actual
26/01/2004
Date of last participant enrolment
Anticipated
Actual
1/01/2007
Date of last data collection
Anticipated
Actual
1/01/2007
Sample size
Target
51
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 683 0
Commercial sector/Industry
Name [1] 683 0
Gilead Sciences
Country [1] 683 0
United States of America
Primary sponsor type
Government body
Name
National Centre in HIV Epidemiology and Clincial Research
Address
UNSW Sydney
Country
Australia
Secondary sponsor category [1] 572 0
University
Name [1] 572 0
University of New South Wales
Address [1] 572 0
UNSW Sydney
Country [1] 572 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1875 0
St. Vincent's Hospital Sydney
Ethics committee address [1] 1875 0
Ethics committee country [1] 1875 0
Australia
Date submitted for ethics approval [1] 1875 0
Approval date [1] 1875 0
04/09/2003
Ethics approval number [1] 1875 0
Ethics committee name [2] 1876 0
The Alfred Hospital
Ethics committee address [2] 1876 0
Ethics committee country [2] 1876 0
Australia
Date submitted for ethics approval [2] 1876 0
Approval date [2] 1876 0
Ethics approval number [2] 1876 0
Ethics committee name [3] 1877 0
Thai Red Cross AIDS Research Centre
Ethics committee address [3] 1877 0
Ethics committee country [3] 1877 0
Australia
Date submitted for ethics approval [3] 1877 0
Approval date [3] 1877 0
Ethics approval number [3] 1877 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36059 0
Prof Greggory Dore
Address 36059 0
UNSW Sydney
Country 36059 0
Australia
Phone 36059 0
+61 2 9385 0900
Fax 36059 0
Email 36059 0
gdore@kirby.unsw.edu.au
Contact person for public queries
Name 9666 0
Pip Marks
Address 9666 0
Kirby Institute,
UNSW Sydney
Country 9666 0
Australia
Phone 9666 0
+61 2 93850900
Fax 9666 0
Email 9666 0
pmarks@kirby.unsw.edu.au
Contact person for scientific queries
Name 594 0
Gregory Dore
Address 594 0
Kirby Institute
UNSW Sydney
Country 594 0
Australia
Phone 594 0
+61 2 93850900
Fax 594 0
Email 594 0
gdore@kirby.unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Trial completed prior to 2018


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.