A Post Marketing Survey Study to Evaluate the Safety and Effectiveness of Prezista
The purpose of this study is to assess the safety data of darunavir in a natural clinical practice.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Regulatory Post Marketing Surveillance of Prezista 400mg Tablet|
- Number of patients with adverse events [ Time Frame: Up to 30 days from end of treatment ] [ Designated as safety issue: Yes ]
- Number of patients with viral load [ Time Frame: Screening, Week 12, Week 24 ] [ Designated as safety issue: No ]
- Number of patients with CD4 T-cell count [ Time Frame: Screening, Week 12, Week 24 ] [ Designated as safety issue: No ]
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||October 2016|
|Estimated Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
Patients having Acquired Immune Deficiency Syndrome (AIDS) will be taking darunavir as per recommended doses.
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.
Other Name: Prezista
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01741831
|Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:||JNJ.CT@sylogent.com|
|Korea, Republic of|
|Dae-Gu, Korea, Republic of|
|Study Director:||Janssen Korea, Ltd., Korea Clinical Trial||Janssen Korea, Ltd., Korea|