A Post Marketing Survey Study to Evaluate the Safety and Effectiveness of Intelence
This study has been completed.
Sponsor:
Janssen Korea, Ltd., Korea
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
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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: | 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) |
| 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
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 Intelene PMS ETR-C-11-KR-001-V04 |
| Study First Received: | December 3, 2012 |
| Last Updated: | March 31, 2016 |
| 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:
|
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 September 27, 2016