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

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ClinicalTrials.gov Identifier: NCT01741844
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : April 4, 2016
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to assess the safety data of etravirine in a natural clinical practice.

Condition or disease Intervention/treatment
Acquired Immune Deficiency Syndrome 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 Design
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Actual Enrollment : 57 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Regulatory Post Marketing Surveillance of Intelence Tablet
Study Start Date : September 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Etravirine
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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).


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of patients with adverse events [ Time Frame: Up to 30 days from end of treatment ]

Secondary Outcome Measures :
  1. Number of patients with viral load [ Time Frame: Screening, Week 12, Week 24 ]
  2. Number of patients with CD4 T-cell count [ Time Frame: Screening, Week 12, Week 24 ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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 )
First Posted: December 5, 2012    Key Record Dates
Last Update Posted: April 4, 2016
Last Verified: March 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