A Post Marketing Survey Study to Evaluate the Safety and Effectiveness of Intelence
The purpose of this study is to assess the safety data of etravirine in a natural clinical practice.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Regulatory Post Marketing Surveillance of Intelence Tablet|
- Number of patients with adverse events [ Time Frame: Up to 30 days from end of treatment ] [ Designated as safety issue: Yes ]
- 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 ]
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Patients having Acquired Immune Deficiency Syndrome (AIDS) will be taking etravirine as per recommended doses.
Drug: No intervention
This is an observational study. Etravirine 200 mg will be adminstered twice daily in patients with Acquired Immune Deficiency Syndrome (AIDS).
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.
|Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:||JNJ.CT@sylogent.com|
|Korea, Republic of|
|Dae-Gu, Korea, Republic of|
|Study Director:||Janssen Korea, Ltd., Korea Clinical Trial||Janssen Korea, Ltd., Korea|