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Tenofovir Disoproxil Fumarate (Tenofovir DF) Versus Emtricitabine/Tenofovir DF in Subjects Resistant to Lamivudine

NCT00737568 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2016-03-11

Study results available
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Summary

The aim of therapy for the treatment of chronic hepatitis B virus (HBV) is to maintain suppression of viral replication to prevent the emergence of complications, which requires long-term therapy. Durable suppression of viral replication is achieved in the treatment of chronic viral diseases by preventing of the emergence of drug-resistant mutations. The clinical guidelines for the management of lamivudine resistant patients are variable. Some recommend switching to another agent without cross-resistance, while others recommend adding on another agent without cross-resistance. Limited clinical data exists to demonstrate whether tenofovir disoproxil fumarate (tenofovir DF; TDF) is an effective monotherapy for lamivudine resistant patients or if it should be used as part of a combination therapy regimen.

This study is designed to evaluate the effectiveness, safety, and tolerability of tenofovir DF monotherapy versus emtricitabine (FTC)/tenofovir DF combination therapy in participants with chronic HBV with lamivudine resistance (presence of the rtM204I/V mutation with or without the rtL180M mutation) over a 240-week period. Participants in this study must be receiving lamivudine treatment at the time of enrollment.

Conditions

Interventions

DRUG

TDF

Tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg tablet administered orally once daily

DRUG

FTC/TDF

Emtricitabine (FTC)/TDF 200/300 mg fixed-dose combination tablet administered orally once daily

DRUG

TDF Placebo

TDF placebo tablet administered orally once daily

DRUG

FTC/TDF Placebo

FTC/TDF placebo tablet administered orally once daily

Sponsors & Collaborators

Principal Investigators

  • John Flaherty, PharmD · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2011-11-30
Completion
2015-02-28

Countries

  • United States
  • Austria
  • Bulgaria
  • Canada
  • Czechia
  • Germany
  • Greece
  • Hungary
  • New Zealand
  • Poland
  • Romania
  • Serbia
  • Spain
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00737568 on ClinicalTrials.gov