A Post Marketing Survey Study to Evaluate the Safety and Effectiveness of Intelence
This study is currently recruiting participants.
Verified May 2013 by Janssen Korea, Ltd., Korea
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: May 7, 2013
Last verified: May 2013
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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:
Genetics Home Reference related topics:
complement factor I deficiency
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 ] [ 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 ]
| Estimated Enrollment: | 3000 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01741844
Contacts
| Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: | JNJ.CT@sylogent.com |
Locations
| Korea, Republic of | |
| Recruiting | |
| 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
Additional 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: | May 7, 2013 |
| 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 Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013