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

September 11, 2005
September 19, 2005
April 1, 2015
January 2004
January 2007   (Final data collection date for primary outcome measure)
To compare HBV DNA suppression to levels below the limit of detection (<400 copies/ml) by week 48 in each group
Same as current
Complete list of historical versions of study NCT00192595 on Archive Site
-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;
To evaluate the emergence of HBV resistance at 48 weeks; To compare the proportion of patients with undetectable HBV DNA at weeks 12 and 24 in each treatment group; To compare the proportion of patients who achieve HBeAg and HBsAg seroconversion at weeks
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Tenofovir in HIV/HBV Coinfection
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)
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)
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • HIV Infection
  • Hepatitis B Coinfection
  • Drug: Tenofovir
  • Drug: Zidovudine (AZT), lamivudine (LAM), efavirenz (EFV)
  • Active Comparator: Arm 1:
    Zidovudine (AZT), lamivudine (LAM), efavirenz (EFV)
    Intervention: Drug: Zidovudine (AZT), lamivudine (LAM), efavirenz (EFV)
  • Experimental: Arm 2
    Zidovudine (AZT), tenofovir (TDF), efavirenz (EFV)
    Intervention: Drug: Tenofovir
  • Experimental: Amr 3
    Lamivudine (LAM), tenofovir (TDF), efavirenz (EFV)
    Intervention: Drug: Tenofovir

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2007
January 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Australia,   Thailand
Not Provided
Not Provided
A/Prof Gregory J Dore, National Centre in HIV Epidemiology and Clinical Research, Univeristy of New South Wales
Kirby Institute
  • The University of New South Wales
  • Gilead Sciences
Principal Investigator: Greg Dore, MBBS, FRACP National Centre in HIV Epidemiology and Clinical Research.
Kirby Institute
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP