Tenofovir in HIV/HBV Coinfection

Phase 4CompletedNCT00192595

Kirby Institute36 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV Infection Hepatitis B Coinfection

Interventions

TenofovirDRUG

Zidovudine (AZT), lamivudine (LAM), efavirenz (EFV)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (3)

St. Vincent's Hospital

Darlinghurst, New South Wales, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Thai Red Cross AIDS Research Centre

Bangkok, Thailand

Outcomes

Primary Outcomes

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

Secondary Outcomes

-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;

Data from ClinicalTrials.gov

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