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TMC278-TiDP6-C209: A Clinical Trial in Treatment Naive HIV-1 Patients Comparing TMC278 to Efavirenz in Combination With Tenofovir + Emtricitabine.

NCT00540449 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 694

Last updated 2016-03-29

Study results available
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Summary

The purpose of this trial is to compare the effectiveness, safety and tolerability of TMC278 given at a dose of 25 mg once daily versus efavirenz (EFV) at a dose of 600 mg once daily, when combined with a fixed background regimen consisting of emtricitabine (FTC) + tenofovir disoproxil fumarate (TDF), in HIV-1 infected patients who have not yet taken any anti-HIV drugs. The following evaluations will be done: antiviral activity, immunologic changes, and viral geno-/phenotype evolution, relationship of Pharmacokinetics (PK) and PK/Pharmacodynamics, medical resource utilization and treatment adherence.

Conditions

  • HIV Infections
  • HIV-1
  • Human Immunodeficiency Virus Type 1

Interventions

DRUG

TMC278

25 mg tablet once daily for 96 weeks

DRUG

Efavirenz

600mg once daily for 96 weeks

Sponsors & Collaborators

  • Tibotec Pharmaceuticals, Ireland

    lead INDUSTRY

Principal Investigators

  • Tibotec Pharmaceuticals Clinical Trial · Tibotec Pharmaceutical Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2010-02-28
Completion
2011-12-31

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Brazil
  • Canada
  • Denmark
  • France
  • Mexico
  • Netherlands
  • Portugal
  • Puerto Rico
  • Romania
  • Russia
  • South Africa
  • Spain
  • Sweden
  • Taiwan
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT00540449 on ClinicalTrials.gov