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Virological and Clinical Anti-Hepatitis B Virus (HBV) Efficacy of Tenofovir and Emtricitabine in Patients With HIV/HBV co-Infection

NCT ID: NCT00127959

Last Updated: 2007-04-24

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2006-08-31

Brief Summary

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This is a randomized multicentre trial of emtricitabine (FTC) versus tenofovir (TDF)/FTC in antiretroviral naive subjects with HIV/HBV co-infection over 48 weeks (Clinical Trial A).

Plus, a 12 week viral kinetic substudy comparing a subgroup of patients on Clinical Trial A is being conducted. (Substudy A1)

Detailed Description

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This is a randomized multicentre trial of FTC vs TDF/FTC in antiretroviral naive subjects with HIV/HBV co-infection over 48 weeks (Clinical Trial A).

Plus, a 12 week viral kinetic substudy comparing a subgroup of patients on Clinical Trial A is being conducted. (Substudy A1)

Primary Objectives:

* To compare the proportion of subjects with HBV DNA levels below the limit of detection (\<400 copies/ml) by week 48 in each treatment group

Secondary Objectives:

* To evaluate the emergence of HBV resistance at 48 weeks
* To compare the proportion of patients with undetectable HBV DNA at weeks 12 and 24 in each treatment group
* To compare the proportion of patients who achieve HBeAg and HBsAg seroconversion at weeks 12, 24 and 48 during the study
* To compare changes in ALT from baseline and the rate of hepatic cytolysis (ALT\>5x ULN)
* To compare suppression of HIV-1 RNA and changes in CD4/CD8 counts over 48 weeks
* To compare the effect of therapy on histological changes in the liver and the presence of ccc-DNA

Enrollment:

* 24 patients in Clinical trial A (of whom 16 enter substudy A1).

Clinical Trial A:

* Patients with HIV/HBV co-infection who are naive to HIV/HBV therapy, have detectable HBV viraemia and are willing to start antiretroviral therapy.

Inclusion Criteria:

* Written informed consent
* Documented HIV infection
* Age 18 - 70 years
* HBV DNA \> 106 copies/ml

Randomization:

* Arm 1: Zidovudine (AZT), emtricitabine (FTC), efavirenz (EFV)
* Arm 2: Tenofovir (TDF), emtricitabine (FTC), efavirenz (EFV)

Conditions

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HIV Infections Hepatitis B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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tenofovir

Intervention Type DRUG

emtricitabine

Intervention Type DRUG

zidovudine

Intervention Type DRUG

efavirenz

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Written informed consent
* Documented HIV infection
* Age 18 - 70 years
* HBV DNA \> 10E6 copies/ml
* ALT \< 10 x ULN (upper limit of normal)
* Creatinine \<= 2.0mg/dl
* Platelet count \>= 50,000/mm3
* HIV-1 therapy naive
* No prior exposure to anti-HBV agents

Exclusion Criteria

* Hepatitis C viral RNA (CV-RNA) positive or Anti-hepatitis A virus immunoglobulin M (HAV IgM) positive
* Acute hepatitis (serum ALT \> 1000 U/L)
* Prior LAM, TDF, or adefovir dipivoxil (ADV) therapy
* Active opportunistic infection
* Pregnancy or lactation
* Other chronic liver disease
* Concurrent malignancy requiring cytotoxic chemotherapy
* Decompensated or Child's C cirrhosis
* Alfa-fetoprotein (AFP) \> 3X ULN (unless negative computed tomography \[CT\] scan or magnetic resonance imaging \[MRI\] within 3 months of entry date)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role collaborator

International Antiviral Therapy Evaluation Center

OTHER

Sponsor Role lead

Principal Investigators

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Joep M.A. Lange, MD PhD

Role: STUDY_CHAIR

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Kiat Ruxrungtham, MD PhD

Role: PRINCIPAL_INVESTIGATOR

HIVNAT Bangkok

Jan Prins, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Locations

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Academic Medical Center

Amsterdam, North Holland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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IAT-0038-04

Identifier Type: -

Identifier Source: org_study_id