NCT00192595

Tenofovir in HIV/HBV Coinfection

Virological and Clinical Anti-HBV Efficacy of Tenofovir in Antiretroviral naïve Patients With HIV/HBV Co-infection

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Kirby Institute · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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)

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)

Conditions

• HIV Infection
• Hepatitis B Coinfection

Interventions

Type	Name	Description
DRUG	Tenofovir
DRUG	Zidovudine (AZT), lamivudine (LAM), efavirenz (EFV)

Timeline

• Start date: 2004-01-01
• Primary completion: 2007-01-01
• Completion: 2007-01-01
• First posted: 2005-09-19
• Last updated: 2015-04-01

Locations

3 sites across 2 countries: Australia, Thailand