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

Acquired Immune Deficiency Syndrome Clinical Trial

Official title:

Regulatory Post Marketing Surveillance of Prezista 400mg Tablet

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01741831
• Other study ID #: CR100805
• Secondary ID: TMC114HIV4074Pre
• Status: Completed
• Phase: Phase 4
• First received: December 3, 2012
• Last updated: December 2, 2016
• Start date: July 2012
• Est. completion date: October 2016

Study information

• Verified date: December 2016
• Source: Janssen Korea, Ltd., Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug AdministrationRepublic of Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acquired Immune Deficiency Syndrome
• Acquired Immunodeficiency Syndrome
• HIV Infections
• Immunologic Deficiency Syndromes

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Korea, Ltd., Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with adverse events		Up to 30 days from end of treatment	Yes
Secondary	Number of patients with viral load		Screening, Week 12, Week 24	No
Secondary	Number of patients with CD4 T-cell count		Screening, Week 12, Week 24	No