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

NCT00127959 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2007-04-24

No results posted yet for this study

Summary

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)

Conditions

Interventions

DRUG

tenofovir

DRUG

emtricitabine

DRUG

zidovudine

DRUG

efavirenz

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • International Antiviral Therapy Evaluation Center

    lead OTHER

Principal Investigators

  • Joep M.A. Lange, MD PhD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  • Kiat Ruxrungtham, MD PhD · HIVNAT Bangkok

  • Jan Prins, MD PhD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2004-03-31
Completion
2006-08-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
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 NCT00127959 on ClinicalTrials.gov