A Post Marketing Survey Study to Evaluate the Safety and Effectiveness of Intelence
- Registration Number
- NCT01741844
- Lead Sponsor
- Janssen Korea, Ltd., Korea
- Brief Summary
The purpose of this study is to assess the safety data of etravirine in a natural clinical practice.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Etravirine No intervention Patients having Acquired Immune Deficiency Syndrome (AIDS) will be taking etravirine as per recommended doses.
- Primary Outcome Measures
Name Time Method Number of patients with adverse events Up to 30 days from end of treatment
- Secondary Outcome Measures
Name Time Method Number of patients with viral load Screening, Week 12, Week 24 Number of patients with CD4 T-cell count Screening, Week 12, Week 24