Tenofovir in HIV/HBV Coinfection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2007-01-31

Brief Summary

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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)

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Detailed Description

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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

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HIV Infection Hepatitis B Coinfection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1:

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

Arm 2

Zidovudine (AZT), tenofovir (TDF), efavirenz (EFV)

Group Type EXPERIMENTAL

Tenofovir

Intervention Type DRUG

Amr 3

Lamivudine (LAM), tenofovir (TDF), efavirenz (EFV)

Group Type EXPERIMENTAL

Tenofovir

Intervention Type DRUG

Interventions

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Tenofovir

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No