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

Janssen Korea, Ltd., Korea57 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Acquired Immune Deficiency Syndrome

Interventions

No interventionDRUG

This is an observational study. Etravirine 200 mg will be adminstered twice daily in patients with Acquired Immune Deficiency Syndrome (AIDS).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Daegu, South Korea

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

Time frame: Screening, Week 12, Week 24

Number of patients with CD4 T-cell count

Time frame: Screening, Week 12, Week 24

Data from ClinicalTrials.gov

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