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

Acquired Immune Deficiency Syndrome Clinical Trial

Official title:

Regulatory Post Marketing Surveillance of Intelence Tablet

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01741844
• Other study ID #: CR100806
• Secondary ID: TMC125HIV4017Int
• Status: Completed
• Phase: Phase 4
• First received: December 3, 2012
• Last updated: March 31, 2016
• Start date: September 2012
• Est. completion date: July 2014

Study information

• Verified date: March 2016
• Source: Janssen Korea, Ltd., Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug AdministrationRepublic of Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acquired Immune Deficiency Syndrome
• Acquired Immunodeficiency Syndrome
• HIV Infections
• Immunologic Deficiency Syndromes

Intervention

Drug:
• No intervention
This is an observational study. Etravirine 200 mg will be adminstered twice daily in patients with Acquired Immune Deficiency Syndrome (AIDS).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Korea, Ltd., Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with adverse events		Up to 30 days from end of treatment	Yes
Secondary	Number of patients with viral load		Screening, Week 12, Week 24	No
Secondary	Number of patients with CD4 T-cell count		Screening, Week 12, Week 24	No