Overview

This trial is active, not recruiting.

Condition acquired immune deficiency syndrome
Treatment no intervention
Phase phase 4
Sponsor Janssen Korea, Ltd., Korea
Start date July 2012
End date October 2016
Trial size 3000 participants
Trial identifier NCT01741831, CR100805, DRV-C-11-KR-001-V06, Prezista PMS, TMC114HIV4074

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Patients having Acquired Immune Deficiency Syndrome (AIDS) will be taking darunavir as per recommended doses.
no intervention Prezista
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.

Primary Outcomes

Measure
Number of patients with adverse events
time frame: Up to 30 days from end of treatment

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Regulatory Post Marketing Surveillance of Prezista 400mg Tablet
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Janssen Korea, Ltd., Korea.