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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01741831
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : December 5, 2016
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea

Tracking Information
First Submitted Date December 3, 2012
First Posted Date December 5, 2012
Last Update Posted Date December 5, 2016
Study Start Date July 2012
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 4, 2012)
Number of patients with adverse events [ Time Frame: Up to 30 days from end of treatment ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 4, 2012)
  • Number of patients with viral load [ Time Frame: Screening, Week 12, Week 24 ]
  • Number of patients with CD4 T-cell count [ Time Frame: Screening, Week 12, Week 24 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Post Marketing Survey Study to Evaluate the Safety and Effectiveness of Prezista
Official Title Regulatory Post Marketing Surveillance of Prezista 400mg Tablet
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 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.
Condition Acquired Immune Deficiency Syndrome
Intervention 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
Study Groups/Cohorts Darunavir
Patients having Acquired Immune Deficiency Syndrome (AIDS) will be taking darunavir as per recommended doses.
Intervention: Drug: No intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 2, 2016)
225
Original Estimated Enrollment
 (submitted: December 4, 2012)
3000
Actual Study Completion Date October 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT01741831
Other Study ID Numbers CR100805
TMC114HIV4074 ( Other Identifier: Janssen Korea, Ltd., Korea )
Prezista PMS ( Other Identifier: Janssen Korea, Ltd., Korea )
DRV-C-11-KR-001-V06 ( Other Identifier: Janssen Korea, Ltd., Korea )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Janssen Korea, Ltd., Korea
Study Sponsor Janssen Korea, Ltd., Korea
Collaborators Not Provided
Investigators
Study Director: Janssen Korea, Ltd., Korea Clinical Trial Janssen Korea, Ltd., Korea
PRS Account Janssen Korea, Ltd., Korea
Verification Date December 2016