NCT01741831

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

Regulatory Post Marketing Surveillance of Prezista 400mg Tablet

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 225 (actual)
• Sponsor: Janssen Korea, Ltd., Korea · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acquired Immune Deficiency Syndrome

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2012-07-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2012-12-05
• Last updated: 2016-12-05

Locations

1 site across 1 country: South Korea