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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT01741844
First received: December 3, 2012
Last updated: June 12, 2014
Last verified: June 2014

December 3, 2012
June 12, 2014
September 2012
June 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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
  • Number of patients with CD4 T-cell count [ Time Frame: Screening, Week 12, Week 24 ] [ Designated as safety issue: No ]
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.
 
Active, not recruiting
3000
June 2014
June 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01741844
CR100806, TMC125HIV4017, Intelene PMS, ETR-C-11-KR-001-V04
No
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
June 2014

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