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

NCT ID: NCT01741831

Last Updated: 2016-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

225 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2016-10-31

Brief Summary

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

Detailed Description

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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 darunavir in treatment of Acquired Immune Deficiency Syndrome (AIDS) in a natural clinical practice.

Conditions

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Acquired Immune Deficiency Syndrome

Keywords

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Acquired Immune Deficiency Syndrome AIDS TMC114 Darunavir Prezista

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Darunavir

Patients having Acquired Immune Deficiency Syndrome (AIDS) will be taking darunavir as per recommended doses.

No intervention

Intervention Type DRUG

This is an observational study. Darunavir will be administered as per the recommended doses and will be given orally for a period of 24 weeks. For treatment naive (never received treatment for AIDS) patients: Darunavir 800 mg will be adminstered along with ritonavir 100 mg once daily. For experienced patients: Darunavir 600 mg will be administered along with ritonavir 100 mg twice daily.

Interventions

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No intervention

This is an observational study. Darunavir will be administered as per the recommended doses and will be given orally for a period of 24 weeks. For treatment naive (never received treatment for AIDS) patients: Darunavir 800 mg will be adminstered along with ritonavir 100 mg once daily. For experienced patients: Darunavir 600 mg will be administered along with ritonavir 100 mg twice daily.

Intervention Type DRUG

Other Intervention Names

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Prezista

Eligibility Criteria

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Inclusion Criteria

* Patients who are prescribed with darunavir for treatment of Acquired Immune Deficiency Syndrome (AIDS)

Exclusion Criteria

* Known hypersensitivity to Prezista
* Prezista coadministered with medicinal products that are highly dependent on CYP3A for clearance
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Korea, Ltd., Korea

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Korea, Ltd., Korea Clinical Trial

Role: STUDY_DIRECTOR

Janssen Korea, Ltd., Korea

Locations

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Daegu, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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TMC114HIV4074

Identifier Type: OTHER

Identifier Source: secondary_id

Prezista PMS

Identifier Type: OTHER

Identifier Source: secondary_id

DRV-C-11-KR-001-V06

Identifier Type: OTHER

Identifier Source: secondary_id

CR100805

Identifier Type: -

Identifier Source: org_study_id