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Clinical Trials/NCT01741831
NCT01741831CompletedNot Applicable

Regulatory Post Marketing Surveillance of Prezista 400mg Tablet

Janssen Korea, Ltd., Korea0 sites225 target enrollmentStarted: July 2012Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
225
Primary Endpoint
Number of patients with adverse events
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to assess the safety data of darunavir 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 darunavir in treatment of Acquired Immune Deficiency Syndrome (AIDS) in a natural clinical practice.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Darunavir

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

Intervention: No intervention (Drug)

Outcomes

Primary Outcomes

Number of patients with adverse events

Time Frame: Up to 30 days from end of treatment

Secondary Outcomes

  • Number of patients with viral load(Screening, Week 12, Week 24)
  • Number of patients with CD4 T-cell count(Screening, Week 12, Week 24)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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