A Post Marketing Survey Study to Evaluate the Safety and Effectiveness of Prezista
NCT01741831 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 225
Last updated 2016-12-05
Summary
The purpose of this study is to assess the safety data of darunavir in a natural clinical practice.
Conditions
- Acquired Immune Deficiency Syndrome
Interventions
- 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.
Sponsors & Collaborators
-
Janssen Korea, Ltd., Korea
lead INDUSTRY
Principal Investigators
-
Janssen Korea, Ltd., Korea Clinical Trial · Janssen Korea, Ltd., Korea
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-07-31
- Primary Completion
- 2016-10-31
- Completion
- 2016-10-31
Countries
- South Korea
Study Locations
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