NCT01741844CompletedNot Applicable
Regulatory Post Marketing Surveillance of Intelence Tablet
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Janssen Korea, Ltd., Korea
- Enrollment
- 57
- Primary Endpoint
- Number of patients with adverse events
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Etravirine
Patients having Acquired Immune Deficiency Syndrome (AIDS) will be taking etravirine as per recommended doses.
Intervention: No intervention (Drug)
Outcomes
Primary Outcomes
Number of patients with adverse events
Time Frame: Up to 30 days from end of treatment
Secondary Outcomes
- Number of patients with viral load(Screening, Week 12, Week 24)
- Number of patients with CD4 T-cell count(Screening, Week 12, Week 24)
Investigators
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