Tenofovir in HIV/HBV Coinfection (TICO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00192595
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : April 1, 2015
The University of New South Wales
Gilead Sciences
Information provided by:
Kirby Institute

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)

Condition or disease Intervention/treatment Phase
HIV Infection Hepatitis B Coinfection Drug: Tenofovir Drug: Zidovudine (AZT), lamivudine (LAM), efavirenz (EFV) Phase 4

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  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Virological and Clinical Anti-HBV Efficacy of Tenofovir in Antiretroviral naïve Patients With HIV/HBV Co-infection
Study Start Date : January 2004
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Arm 1:
Zidovudine (AZT), lamivudine (LAM), efavirenz (EFV)
Drug: Zidovudine (AZT), lamivudine (LAM), efavirenz (EFV)
Experimental: Arm 2
Zidovudine (AZT), tenofovir (TDF), efavirenz (EFV)
Drug: Tenofovir
Experimental: Amr 3
Lamivudine (LAM), tenofovir (TDF), efavirenz (EFV)
Drug: Tenofovir

Primary Outcome Measures :
  1. To compare HBV DNA suppression to levels below the limit of detection (<400 copies/ml) by week 48 in each group

Secondary Outcome Measures :
  1. -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;

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00192595

Australia, New South Wales
St. Vincent's Hospital
Darlinghurst, New South Wales, Australia, 2010
Australia, Victoria
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Thai Red Cross AIDS Research Centre
Bangkok, Thailand
Sponsors and Collaborators
Kirby Institute
The University of New South Wales
Gilead Sciences
Principal Investigator: Greg Dore, MBBS, FRACP National Centre in HIV Epidemiology and Clinical Research.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: A/Prof Gregory J Dore, National Centre in HIV Epidemiology and Clinical Research, Univeristy of New South Wales Identifier: NCT00192595     History of Changes
Other Study ID Numbers: VHWG001
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: March 2015

Keywords provided by Kirby Institute:
Hepatitis B
Treatment Naive

Additional relevant MeSH terms:
HIV Infections
Hepatitis B
Liver Diseases
Digestive System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Viral, Human
Parasitic Diseases
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents