A Post Marketing Survey Study to Evaluate the Safety and... | NCT01741844

Studies
A Post Marketing Survey Study to Evaluate the Safety and Effectiveness of Intelence

NCT01741844

Sponsor

Janssen Korea, Ltd., Korea

Status

Completed

Last Update Posted

Apr 4, 2016Estimated

Enrollment

57Actual

Phase

Not provided

Conditions

Acquired Immune Deficiency Syndrome

Interventions

No intervention

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description
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

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Jul 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Dec 3, 2012

First Submission Date that Met QC Criteria

Dec 4, 2012

First Posted Date

Dec 5, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2016

Last Update Posted Date

Apr 4, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

57Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Etravirine		Patients having Acquired Immune Deficiency Syndrome (AIDS) will be taking etravirine as per recommended doses.	Drug: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Drug	This is an observational study. Etravirine 200 mg will be adminstered twice daily in patients with Acquired Immune Deficiency Syndrome (AIDS).	Etravirine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with adverse events		Up to 30 days from end of treatment

Secondary Outcomes

Measure	Description	Time Frame
Number of patients with viral load		Screening, Week 12, Week 24
Number of patients with CD4 T-cell count		Screening, Week 12, Week 24

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Janssen Korea, Ltd., Korea Clinical Trial	Janssen Korea, Ltd., Korea	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Daegu			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D000163	Acquired Immunodeficiency Syndrome

Ancestor Terms

ID	Term
D015658	HIV Infections
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided