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.

Study Overview

• Status: Completed
• Conditions: Acquired Immune Deficiency Syndrome
• Intervention / Treatment: Drug: No intervention

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
• Enrollment (Actual): 225

Contacts and Locations

Study Locations

• Korea, Republic of
  • Dae-Gu, Korea, Republic of

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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 Names: Prezista

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients with adverse events	Up to 30 days from end of treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of patients with viral load	Screening, Week 12, Week 24
Number of patients with CD4 T-cell count	Screening, Week 12, Week 24

Collaborators and Investigators

• Sponsor: Janssen Korea, Ltd., Korea

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: December 3, 2012
• First Submitted That Met QC Criteria: December 4, 2012
• First Posted (Estimate): December 5, 2012

Study Record Updates

• Last Update Posted (Estimate): December 5, 2016
• Last Update Submitted That Met QC Criteria: December 2, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: AIDS; Darunavir; Prezista; TMC114; Acquired Immune Deficiency Syndrome
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Darunavir
• 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)