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Comparison of Epzicom and Truvada for the Initial Once Daily HIV Treatment

NCT00544128 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2015-03-30

No results posted yet for this study

Summary

A non-inferiority randomized control trial in treatment naïve HIV patients to compare virologic effect of two backbone regimens with Epzicom (lamivudine and abacavir) and Truvada (emtricitabine and tenofovir). Both arms are treated with fixed combination of ritonavir boosted atazanavir as key drugs.

Conditions

  • HIV Infections

Interventions

DRUG

lamivudine, abacavir , ritonavir, atazanavir

Patients are treated with Epzicom (lamivudine 300mg and abacavir 600mg) combined with ritonavir 100mg boosted atazanavir 300mg

DRUG

emtricitabine, tenofovir, ritonavir, atazanavir

Patients are treated with Truvada (emtricitabine 200mg and tenofovir 300mg) combined with ritonavir 100mg boosted atazanavir 300mg.

Sponsors & Collaborators

  • Ministry of Health, Labour and Welfare, Japan

    collaborator OTHER_GOV

  • International Medical Center of Japan

    lead OTHER_GOV

Principal Investigators

  • Shinichi Oka, MD · International Medical Center of Japan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • Japan

Study Locations

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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 NCT00544128 on ClinicalTrials.gov