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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 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: August 7, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention Phase
Acquired Immune Deficiency Syndrome
Drug: No intervention
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Regulatory Post Marketing Surveillance of Prezista 400mg Tablet

Resource links provided by NLM:


Further study details as provided by Janssen Korea, Ltd., Korea:

Primary Outcome Measures:
  • Number of patients with adverse events [ Time Frame: Up to 30 days from end of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 3000
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)
Groups/Cohorts Assigned Interventions
Darunavir
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01741831

Contacts
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

Locations
Korea, Republic of
Recruiting
Dae-Gu, Korea, Republic of
Sponsors and Collaborators
Janssen Korea, Ltd., Korea
Investigators
Study Director: Janssen Korea, Ltd., Korea Clinical Trial Janssen Korea, Ltd., Korea
  More Information

Additional Information:
No publications provided

Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT01741831     History of Changes
Other Study ID Numbers: CR100805, TMC114HIV4074, Prezista PMS, DRV-C-11-KR-001-V06
Study First Received: December 3, 2012
Last Updated: August 7, 2014
Health Authority: Korea: Food and Drug Administration
Republic of Korea: Food and Drug Administration

Keywords provided by Janssen Korea, Ltd., Korea:
Acquired Immune Deficiency Syndrome
AIDS
TMC114
Darunavir
Prezista

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Darunavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014