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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Janssen Korea, Ltd., Korea

ClinicalTrials.gov Identifier:

NCT01741844

First received: December 3, 2012

Last updated: March 31, 2016

Last verified: March 2016

History of Changes

Purpose

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

Condition	Intervention	Phase
Acquired Immune Deficiency Syndrome	Drug: No intervention	Phase 4


Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Regulatory Post Marketing Surveillance of Intelence Tablet

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Etravirine

U.S. FDA Resources

Further study details as provided by Janssen Korea, Ltd., Korea:

Primary Outcome Measures:

Number of patients with adverse events [ Time Frame: Up to 30 days from end of treatment ]

Secondary Outcome Measures:

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 ]


Enrollment:	57
Study Start Date:	September 2012
Study Completion Date:	July 2014
Primary Completion Date:	July 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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).

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
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.

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01741844

Locations


Korea, Republic of

Dae-Gu, Korea, Republic of

Sponsors and Collaborators

Janssen Korea, Ltd., Korea

Investigators


Study Director:	Janssen Korea, Ltd., Korea Clinical Trial	Janssen Korea, Ltd., Korea

More Information


Responsible Party:	Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:	NCT01741844 History of Changes
Other Study ID Numbers:	CR100806 TMC125HIV4017 ( Other Identifier: Janssen Korea, Ltd., Korea ) Intelene PMS ( Other Identifier: Janssen Korea, Ltd., Korea ) ETR-C-11-KR-001-V04 ( Other Identifier: Janssen Korea, Ltd., Korea )
Study First Received:	December 3, 2012
Last Updated:	March 31, 2016

Keywords provided by Janssen Korea, Ltd., Korea:


Acquired Immune Deficiency Syndrome TMC125 Etravirine Intelence AIDS

Additional relevant MeSH terms:


Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases	Slow Virus Diseases Etravirine Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents

ClinicalTrials.gov processed this record on July 26, 2017

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