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

Completed

• Conditions: Acquired Immune Deficiency Syndrome
• Interventions: Drug: No intervention

• Registration Number: NCT01741831
• Lead Sponsor: Janssen Korea, Ltd., Korea

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 Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-12-03
• Study First Submitted QC: 2012-12-04
• Study First Posted: 2012-12-05
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-02
• Last Update Posted: 2016-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Darunavir	No intervention	Patients having Acquired Immune Deficiency Syndrome (AIDS) will be taking darunavir as per recommended doses.

Primary Outcome Measures

Name	Time	Method
Number of patients with adverse events	Up to 30 days from end of treatment

Secondary Outcome Measures

Name	Time	Method
Number of patients with viral load	Screening, Week 12, Week 24
Number of patients with CD4 T-cell count	Screening, Week 12, Week 24