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A Clinical Trial Comparing the Tolerability of Etravirine to Efavirenz in Combination With 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Treatment-naive HIV-1 Infected Patients

NCT00903682 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 157

Last updated 2013-01-14

Study results available
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Summary

The purpose of this study is to compare the neuropsychiatric adverse event profiles of etravirine 400mg once daily versus efavirenz 600mg once daily, in combination with 2 N(t)RTIs, in approximately 150 treatment-naÃ-ve HIV-1 infected patients. Safety, tolerability and efficacy of both treatment arms will be assessed throughout the study.

Conditions

  • HIV Infection
  • HIV
  • Acquired Immunodeficiency Syndrome

Interventions

DRUG

etravirine (ETR, TMC125)

400mg once daily (4x100mg tablet) + 2 NRTI + 1 EFV placebo tablet for 48 weeks

DRUG

efavirenz (EFV)

600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks

Sponsors & Collaborators

  • Janssen-Cilag International NV

    lead INDUSTRY

Principal Investigators

  • Janssen-Cilag International NV Clinical Trial · Janssen-Cilag International NV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-02-28
Completion
2011-01-31

Countries

  • Austria
  • Denmark
  • France
  • Germany
  • Hungary
  • Israel
  • Romania
  • Russia
  • Spain
  • Switzerland
  • 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 NCT00903682 on ClinicalTrials.gov