Clinical Trials

MainTitle

Tenofovir in HIV/HBV Coinfection (TICO)

This study has been completed
Sponsor
Kirby Institute

Collaborator
The University of New South Wales
Gilead Sciences

Information provided by (Responsible Party)
Kirby Institute
ClinicalTrials.gov Identifier
NCT00192595

First received: September 11, 2005
Last updated: March 30, 2015
Last Verified: March 2015
History of Changes
Purpose

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
Drug : Zidovudine (AZT), lamivudine (LAM), efavirenz (EFV)
Phase 4

Study Type: Interventional
Study Design: 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

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)

Arms Assigned Interventions
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

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

Eligibility

Ages Eligible for Study: 18 Years to 70 Years  
Sexes Eligible for Study: All  
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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00192595

Locations

Australia
St. Vincent's Hospital
Darlinghurst, New South Wales, Australia, 2010
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

More Information


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: March 30, 2015  

Keywords provided by Kirby Institute:

Hepatitis B
HIV
Treatment Naive

Additional relevant MeSH terms:
Infection
Hepatitis
HIV Infections
Hepatitis B
Coinfection
Tenofovir
Lamivudine
Zidovudine
Efavirenz

ClinicalTrials.gov processed this data on December 12, 2017
This information is provided by ClinicalTrials.gov.