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

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Acquired Immune Deficiency Syndrome

Treatments: Drug: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT01741844

Intelene PMS (Other Identifier)

CR100806

TMC125HIV4017 (Other Identifier)

ETR-C-11-KR-001-V04 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to assess the safety data of etravirine in a natural clinical practice.

Full 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.

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

57 participants in 1 patient group

Etravirine

Description:

Patients having Acquired Immune Deficiency Syndrome (AIDS) will be taking etravirine as per recommended doses.

Treatment:

Drug: No intervention