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

Regulatory Post Marketing Surveillance of Intelence Tablet

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

Study Overview

• Status: Completed
• Conditions: Acquired Immune Deficiency Syndrome
• Intervention / Treatment: Drug: No intervention

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 Type: Observational
• Enrollment (Actual): 57

Contacts and Locations

Study Locations

• Korea, Republic of
  • Dae-Gu, Korea, Republic of

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will include patients who are diagnosed with Acquired Immune Deficiency Syndrome (AIDS), and who are prescribed with etravirine for treatment of AIDS.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Etravirine; Patients having Acquired Immune Deficiency Syndrome (AIDS) will be taking etravirine as per recommended doses.	Drug: No intervention; This is an observational study. Etravirine 200 mg will be adminstered twice daily in patients with Acquired Immune Deficiency Syndrome (AIDS).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients with adverse events	Up to 30 days from end of treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of patients with viral load	Screening, Week 12, Week 24
Number of patients with CD4 T-cell count	Screening, Week 12, Week 24

Collaborators and Investigators

• Sponsor: Janssen Korea, Ltd., Korea

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ACTUAL): July 1, 2014
• Study Completion (ACTUAL): July 1, 2014

Study Registration Dates

• First Submitted: December 3, 2012
• First Submitted That Met QC Criteria: December 4, 2012
• First Posted (ESTIMATE): December 5, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): April 4, 2016
• Last Update Submitted That Met QC Criteria: March 31, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: AIDS; Etravirine; Intelence; Acquired Immune Deficiency Syndrome; TMC125
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
• Other Study ID Numbers: CR100806; TMC125HIV4017 (OTHER: Janssen Korea, Ltd., Korea); Intelene PMS (OTHER: Janssen Korea, Ltd., Korea); ETR-C-11-KR-001-V04 (OTHER: Janssen Korea, Ltd., Korea)