- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00192595
Tenofovir in HIV/HBV Coinfection (TICO)
March 30, 2015 updated by: Kirby Institute
Virological and Clinical Anti-HBV Efficacy of Tenofovir in Antiretroviral naïve Patients With HIV/HBV Co-infection
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)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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)
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
To compare HBV DNA suppression to levels below the limit of detection (<400 copies/ml) by week 48 in each group
|
Secondary Outcome Measures
Outcome Measure |
---|
-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;
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Greg Dore, MBBS, FRACP, National Centre in HIV Epidemiology and Clinical Research.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2004
Primary Completion (Actual)
January 1, 2007
Study Completion (Actual)
January 1, 2007
Study Registration Dates
First Submitted
September 11, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 19, 2005
Study Record Updates
Last Update Posted (Estimate)
April 1, 2015
Last Update Submitted That Met QC Criteria
March 30, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Virus Diseases
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Infections
- Hepatitis B
- Hepatitis
- Coinfection
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antimetabolites
- Cytochrome P-450 Enzyme Inhibitors
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Cytochrome P-450 CYP2B6 Inducers
- Cytochrome P-450 CYP2C9 Inhibitors
- Cytochrome P-450 CYP2C19 Inhibitors
- Tenofovir
- Lamivudine
- Zidovudine
- Efavirenz
Other Study ID Numbers
- VHWG001
- TICO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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