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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01741844
Other study ID # CR100806
Secondary ID TMC125HIV4017Int
Status Completed
Phase Phase 4
First received December 3, 2012
Last updated March 31, 2016
Start date September 2012
Est. completion date July 2014

Study information

Verified date March 2016
Source Janssen Korea, Ltd., Korea
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug AdministrationRepublic of Korea: Food and Drug Administration
Study type Observational

Clinical Trial Summary

The purpose of this study is to assess the safety data of etravirine in a natural clinical practice.


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.


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Drug:
No intervention
This is an observational study. Etravirine 200 mg will be adminstered twice daily in patients with Acquired Immune Deficiency Syndrome (AIDS).

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Janssen Korea, Ltd., Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients with adverse events Up to 30 days from end of treatment Yes
Secondary Number of patients with viral load Screening, Week 12, Week 24 No
Secondary Number of patients with CD4 T-cell count Screening, Week 12, Week 24 No
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