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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00192595




Registration number
NCT00192595
Ethics application status
Date submitted
11/09/2005
Date registered
19/09/2005
Date last updated
1/04/2015

Titles & IDs
Public title
Tenofovir in HIV/HBV Coinfection
Scientific title
Virological and Clinical Anti-HBV Efficacy of Tenofovir in Antiretroviral naïve Patients With HIV/HBV Co-infection
Secondary ID [1] 0 0
TICO
Secondary ID [2] 0 0
VHWG001
Universal Trial Number (UTN)
Trial acronym
TICO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infection 0 0
Hepatitis B Coinfection 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
Interventional
Description of intervention(s) / exposure
Active comparator: Arm 1: - Zidovudine (AZT), lamivudine (LAM), efavirenz (EFV)

Experimental: Arm 2 - Zidovudine (AZT), tenofovir (TDF), efavirenz (EFV)

Experimental: Amr 3 - Lamivudine (LAM), tenofovir (TDF), efavirenz (EFV)
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To compare HBV DNA suppression to levels below the limit of detection (<400 copies/ml) by week 48 in each group
Timepoint [1] 0 0
Secondary outcome [1] 0 0
-HBV resistance at 48 weeks; -undetectable HBV DNA at weeks 12 & 24; -HBeAg and HBsAg seroconversion at weeks 24 & 48; -ALT chnages and rate of hepatic cytolysis; -HIV-1 RNA supression and CD4/CD8 changes over 48 weeks;
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
* Written informed consent
* Documented HIV infection (positive serology for HIV-1 and detectable HIV-1 RNA)
* Age 18 - 70 years
* 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 naïve
* 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, hemochromatosis, 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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2007
Sample size
Target
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
St. Vincent's Hospital - Darlinghurst
Recruitment hospital [2] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Thailand
State/province [1] 0 0
Bangkok

Funding & Sponsors
Primary sponsor type
Government body
Name
Kirby Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The University of New South Wales
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
The purpose of the study is to compare the effectiveness of 3 different treatment regimens in reducing or clearing the Hepatitis B Virus in patients infected with HIV and Hepatitis B (co-infection)
Trial website
https://clinicaltrials.gov/study/NCT00192595
Trial related presentations / publications
Avihingsanon A, Matthews GV, Lewin SR, Marks P, Sasadeusz J, Cooper DA, Bowden S, Locarnini S, Dore GJ, Ruxrungtham K. Assessment of HBV flare in a randomized clinical trial in HIV/HBV coinfected subjects initiating HBV-active antiretroviral therapy in Thailand. AIDS Res Ther. 2012 Mar 9;9(1):6. doi: 10.1186/1742-6405-9-6.
Matthews GV, Avihingsanon A, Lewin SR, Amin J, Rerknimitr R, Petcharapirat P, Marks P, Sasadeusz J, Cooper DA, Bowden S, Locarnini S, Ruxrungtham K, Dore GJ. A randomized trial of combination hepatitis B therapy in HIV/HBV coinfected antiretroviral naive individuals in Thailand. Hepatology. 2008 Oct;48(4):1062-9. doi: 10.1002/hep.22462.
Public notes

Contacts
Principal investigator
Name 0 0
Greg Dore, MBBS, FRACP
Address 0 0
National Centre in HIV Epidemiology and Clinical Research.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00192595