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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Janssen Korea, Ltd., Korea
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT01741831
First received: December 3, 2012
Last updated: October 15, 2014
Last verified: October 2014

December 3, 2012
October 15, 2014
July 2012
October 2016   (final data collection date for primary outcome measure)
Number of patients with adverse events [ Time Frame: Up to 30 days from end of treatment ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01741831 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Post Marketing Survey Study to Evaluate the Safety and Effectiveness of Prezista
Regulatory Post Marketing Surveillance of Prezista 400mg Tablet

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

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

The study population will include patients who are diagnosed with Acquired Immune Deficiency Syndrome (AIDS), and who are prescribed with darunavir for treatment of AIDS.

Acquired Immune Deficiency Syndrome
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
Darunavir
Patients having Acquired Immune Deficiency Syndrome (AIDS) will be taking darunavir as per recommended doses.
Intervention: Drug: No intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3000
October 2016
October 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
 
NCT01741831
CR100805, TMC114HIV4074, Prezista PMS, DRV-C-11-KR-001-V06
No
Janssen Korea, Ltd., Korea
Janssen Korea, Ltd., Korea
Not Provided
Study Director: Janssen Korea, Ltd., Korea Clinical Trial Janssen Korea, Ltd., Korea
Janssen Korea, Ltd., Korea
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP