Back to resultsTenofovir in HIV/HBV Coinfection (TICO)
Primary Purpose
HIV Infection, Hepatitis B Coinfection
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Tenofovir
Zidovudine (AZT), lamivudine (LAM), efavirenz (EFV)
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infection focused on measuring Hepatitis B, HIV, Treatment Naive
Eligibility Criteria
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 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
Sites / Locations
- St. Vincent's Hospital
- The Alfred Hospital
- Thai Red Cross AIDS Research Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Arm 1:
Arm 2
Amr 3
Arm Description
Zidovudine (AZT), lamivudine (LAM), efavirenz (EFV)
Zidovudine (AZT), tenofovir (TDF), efavirenz (EFV)
Lamivudine (LAM), tenofovir (TDF), efavirenz (EFV)
Outcomes
Primary Outcome Measures
To compare HBV DNA suppression to levels below the limit of detection (<400 copies/ml) by week 48 in each group
Secondary Outcome Measures
-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;
Full Information
NCT ID
NCT00192595
First Posted
September 11, 2005
Last Updated
March 30, 2015
Sponsor
Kirby Institute
Collaborators
The University of New South Wales, Gilead Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00192595
Brief Title
Tenofovir in HIV/HBV Coinfection
Acronym
TICO
Official Title
Virological and Clinical Anti-HBV Efficacy of Tenofovir in Antiretroviral naïve Patients With HIV/HBV Co-infection
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Kirby Institute
Collaborators
The University of New South Wales, Gilead Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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)
Detailed Description
A randomised multi-centre trial of tenofovir vs lamivudine vs tenofovir/lamivudine in antiretroviral naïve subjects with HIV/HBV co-infection over 48 weeks (Clinical Trial A). Plus, a 12 week viral kinetic sub-study comparing a sub-group of the patients on Clinical Trial A with a group of therapy naïve HBV mono-infected subjects (Substudy A1)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection, Hepatitis B Coinfection
Keywords
Hepatitis B, HIV, Treatment Naive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1:
Arm Type
Active Comparator
Arm Description
Zidovudine (AZT), lamivudine (LAM), efavirenz (EFV)
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
Zidovudine (AZT), tenofovir (TDF), efavirenz (EFV)
Arm Title
Amr 3
Arm Type
Experimental
Arm Description
Lamivudine (LAM), tenofovir (TDF), efavirenz (EFV)
Intervention Type
Drug
Intervention Name(s)
Tenofovir
Intervention Type
Drug
Intervention Name(s)
Zidovudine (AZT), lamivudine (LAM), efavirenz (EFV)
Primary Outcome Measure Information:
Title
To compare HBV DNA suppression to levels below the limit of detection (<400 copies/ml) by week 48 in each group
Secondary Outcome Measure Information:
Title
-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;
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Greg Dore, MBBS, FRACP
Organizational Affiliation
National Centre in HIV Epidemiology and Clinical Research.
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Vincent's Hospital
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Thai Red Cross AIDS Research Centre
City
Bangkok
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
22405335
Citation
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.
Results Reference
derived
PubMed Identifier
18697216
Citation
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.
Results Reference
derived
Links:
URL
http://www.med.unsw.edu.au/nchecr
Description
National Centre in HIV Epidemiology and Clinical Research
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Tenofovir in HIV/HBV Coinfection
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