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A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Etravirine Administered in Combination With Other Antiretroviral Agents in Antiretroviral Treatment-Experienced HIV-1 Infected Patients

NCT01422330 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 211

Last updated 2014-10-13

No results posted yet for this study

Summary

The purpose of this study is to learn more about the safety and tolerability of etravirine. Etravirine is a type of non-nucleoside reverse transcriptase inhibitor (NNRTI) which has shown high activity against wild-type human immunodeficiency virus (HIV-1), and HIV strains resistant to other non-nucleotide agents.

Conditions

  • Human Immunodeficiency Virus (HIV) Infection

Interventions

DRUG

Etravirine

Type=exact number, unit=mg, number=100, form=tablet, route=oral use, 2 tablets. Type=exact number, unit=mg, number=200, form=tablet, route=oral use, 1 tablet. The drug is taken twice a day, after meals.

Sponsors & Collaborators

  • Janssen R&D Ireland

    lead INDUSTRY

Principal Investigators

  • Janssen R&D Ireland Clinical Trial · Janssen R&D Ireland

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • United States
  • Argentina
  • France
  • Guatemala
  • Mexico
  • Peru
  • Puerto Rico
  • Romania
  • Russia
  • South Africa
  • Ukraine

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 NCT01422330 on ClinicalTrials.gov