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
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Condition or disease | Intervention/treatment |
---|---|
Acquired Immune Deficiency Syndrome | Drug: No intervention |
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 |

Group/Cohort | Intervention/treatment |
---|---|
Etravirine
Patients having Acquired Immune Deficiency Syndrome (AIDS) will be taking etravirine as per recommended doses.
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Drug: No intervention
This is an observational study. Etravirine 200 mg will be adminstered twice daily in patients with Acquired Immune Deficiency Syndrome (AIDS).
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- Number of patients with adverse events [ Time Frame: Up to 30 days from end of treatment ]
- 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 ]

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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 |
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

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
Korea, Republic of | |
Dae-Gu, Korea, Republic of |
Study Director: | Janssen Korea, Ltd., Korea Clinical Trial | Janssen Korea, Ltd., Korea |
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 |