Tenofovir in HIV/HBV Coinfection

Phase 4

Completed

• Conditions: Hepatitis B Coinfection; HIV Infection
• Interventions: Drug: Zidovudine (AZT), lamivudine (LAM), efavirenz (EFV); Drug: Tenofovir

• Registration Number: NCT00192595
• Lead Sponsor: 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)

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 Timeline

• Study Start: 2004-01
• Study First Submitted: 2005-09-11
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-30
• Last Update Posted: 2015-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1:	Zidovudine (AZT), lamivudine (LAM), efavirenz (EFV)	Zidovudine (AZT), lamivudine (LAM), efavirenz (EFV)
Arm 2	Tenofovir	Zidovudine (AZT), tenofovir (TDF), efavirenz (EFV)
Amr 3	Tenofovir	Lamivudine (LAM), tenofovir (TDF), efavirenz (EFV)

Primary Outcome Measures

Name	Time	Method
To compare HBV DNA suppression to levels below the limit of detection (<400 copies/ml) by week 48 in each group

Secondary Outcome Measures

Name	Time	Method
-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;

Trial Locations

Locations (3)

St. Vincent's Hospital; 🇦🇺 Darlinghurst, New South Wales, Australia

Thai Red Cross AIDS Research Centre; 🇹🇭 Bangkok, Thailand

The Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia