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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT01741844
First received: December 3, 2012
Last updated: March 31, 2016
Last verified: March 2016
December 3, 2012
March 31, 2016
September 2012
July 2014   (Final data collection date for primary outcome measure)
Number of patients with adverse events [ Time Frame: Up to 30 days from end of treatment ]
Same as current
Complete list of historical versions of study NCT01741844 on ClinicalTrials.gov Archive Site
  • Number of patients with viral load [ Time Frame: Screening, Week 12, Week 24 ]
  • Number of patients with CD4 T-cell count [ Time Frame: Screening, Week 12, Week 24 ]
Same as current
Not Provided
Not Provided
 
A Post Marketing Survey Study to Evaluate the Safety and Effectiveness of Intelence
Regulatory Post Marketing Surveillance of Intelence Tablet
The purpose of this study is to assess the safety data of etravirine in a natural clinical practice.
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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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.
Acquired Immune Deficiency Syndrome
Drug: No intervention
This is an observational study. Etravirine 200 mg will be adminstered twice daily in patients with Acquired Immune Deficiency Syndrome (AIDS).
Etravirine
Patients having Acquired Immune Deficiency Syndrome (AIDS) will be taking etravirine as per recommended doses.
Intervention: Drug: No intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
57
July 2014
July 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01741844
CR100806
TMC125HIV4017 ( Other Identifier: Janssen Korea, Ltd., Korea )
Intelene PMS ( Other Identifier: Janssen Korea, Ltd., Korea )
ETR-C-11-KR-001-V04 ( Other Identifier: Janssen Korea, Ltd., Korea )
No
Not Provided
Not Provided
Janssen Korea, Ltd., Korea
Janssen Korea, Ltd., Korea
Not Provided
Study Director: Janssen Korea, Ltd., Korea Clinical Trial Janssen Korea, Ltd., Korea
Janssen Korea, Ltd., Korea
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP