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CompletedNCT01741844Updated Apr 4, 2016

A Post Marketing Survey Study to Evaluate the Safety and Effectiveness of Intelence

An observational study in Acquired Immune Deficiency Syndrome, sponsored by Janssen Korea, Ltd., Korea. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-04.

Sponsored by Janssen Korea, Ltd., Korea · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
57
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to assess the safety data of etravirine in a natural clinical practice.

Read the detailed description

This is a non-interventional (a scientific study to make a clear and easy understanding of the cause and effect relationship), prospective (in which the participants are first identified and then followed forward as time passes), consecutive survey for collecting safety and efficacy data of etravirine in treatment of Acquired Immune Deficiency Syndrome (AIDS) in a natural clinical practice.

02

Conditions studied

  • Acquired Immune Deficiency Syndrome

Keywords

  • Acquired Immune Deficiency Syndrome
  • TMC125
  • Etravirine
  • Intelence
  • AIDS
03

In context

Acquired Immunodeficiency Syndrome

2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.

This study's enrollment of 57 is below the median of 236 across 355 observational studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

Janssen Korea, Ltd., Korea is the lead sponsor of 75 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population will include patients who are diagnosed with Acquired Immune Deficiency Syndrome (AIDS), and who are prescribed with etravirine for treatment of AIDS.

Inclusion criteria

  • Patients who are prescribed with etravirine for treatment of Acquired Immune Deficiency Syndrome (AIDS)

Exclusion criteria

Exclusion Criteria:

  • Known hypersensitivity to Intelence
  • Intelence coadministered with medicinal products that are highly dependent on CYP3A and CYP2C9 for clearance
  • Patients with galactose intoralance, Lapp lactase deficiency, and glucose-galactose malabsorption
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
57 participants (actual)
Patient registry
No

Groups and cohorts

  • Etravirine

    Patients having Acquired Immune Deficiency Syndrome (AIDS) will be taking etravirine as per recommended doses.

    Drug: No intervention

Interventions

  • DrugNo intervention

    This is an observational study. Etravirine 200 mg will be adminstered twice daily in patients with Acquired Immune Deficiency Syndrome (AIDS).

06

What researchers measure

Primary outcomes

  1. Number of patients with adverse events

    Time frame: Up to 30 days from end of treatment

Secondary outcomes

  1. Number of patients with viral load

    Time frame: Screening, Week 12, Week 24

  2. Number of patients with CD4 T-cell count

    Time frame: Screening, Week 12, Week 24

07

Study locations

1 site
  • Dae-Gu, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01741844
Lead sponsor
Janssen Korea, Ltd., Korea
Responsible party
Sponsor
First posted
Dec 5, 2012
Start date
Sep 2012
Primary completion
Jul 2014
Completion
Jul 2014
Last update
Apr 4, 2016

Study contacts

Janssen Korea, Ltd., Korea Clinical Trial
study director · Janssen Korea, Ltd., Korea

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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