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Tenofovir in HIV/HBV Coinfection (TICO)

This study has been completed.
Sponsor:
Collaborators:
The University of New South Wales
Gilead Sciences
Information provided by:
Kirby Institute
ClinicalTrials.gov Identifier:
NCT00192595
First received: September 11, 2005
Last updated: April 8, 2008
Last verified: April 2008
History of Changes
  Purpose

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 Intervention Phase
HIV Infection
Hepatitis B Coinfection
 Drug: Tenofovir
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Virological and Clinical Anti-HBV Efficacy of Tenofovir in Antiretroviral naïve Patients With HIV/HBV co-Infection

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kirby Institute:

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;

Enrollment: 36
Study Start Date: January 2004
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
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)

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00192595

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

Additional Information:
National Centre in HIV Epidemiology and Clinical Research  This link exits the ClinicalTrials.gov site

No publications provided by Kirby Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: A/Prof Gregory J Dore, National Centre in HIV Epidemiology and Clinical Research, Univeristy of New South Wales
ClinicalTrials.gov Identifier: NCT00192595     History of Changes
Other Study ID Numbers: VHWG001, TICO
Study First Received: September 11, 2005
Last Updated: April 8, 2008
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Thailand: Ministry of Public Health

Keywords provided by Kirby Institute:
Hepatitis B
HIV
Treatment Naive

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Hepatitis
Hepatitis A
Hepatitis B
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Liver Diseases
 Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Hepadnaviridae Infections
DNA Virus Infections
Tenofovir
Tenofovir disoproxil
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents

ClinicalTrials.gov processed this record on February 28, 2013