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

Janssen Korea, Ltd., Korea225 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

225

Conditions

Acquired Immune Deficiency Syndrome

Interventions

No interventionDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Daegu, South Korea

Outcomes

Primary Outcomes

Number of patients with adverse events

Time frame: Up to 30 days from end of treatment

Secondary Outcomes

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

Data from ClinicalTrials.gov

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