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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: September 28, 2014
Last verified: September 2014
  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:


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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of patients with viral load [ Time Frame: Screening, Week 12, Week 24 ] [ Designated as safety issue: No ]
  • Number of patients with CD4 T-cell count [ Time Frame: Screening, Week 12, Week 24 ] [ Designated as safety issue: No ]

Enrollment: 7
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
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT01741844     History of Changes
Other Study ID Numbers: CR100806, TMC125HIV4017, Intelene PMS, ETR-C-11-KR-001-V04
Study First Received: December 3, 2012
Last Updated: September 28, 2014
Health Authority: Korea: Food and Drug Administration
Republic of Korea: Food and Drug Administration

Keywords provided by Janssen Korea, Ltd., Korea:
Acquired Immune Deficiency Syndrome
TMC125
Etravirine
Intelence
AIDS

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Syndrome
Disease
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Pathologic Processes
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Etravirine
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014